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pdfSUBCHAPTER E—PESTICIDE PROGRAMS
152.30 Pesticides that may be transferred,
sold, or distributed without registration.
PART 150—GENERAL
Subpart C—Registration Procedures
AUTHORITY: Reorganization Plan No. 3 of
1970 (5 U.S.C. App.).
152.40 Who may apply.
152.42 Application for new registration.
152.43 Alternate formulations.
152.44 Application for amended registration.
152.46 Notification
and
non-notification
changes to registrations.
152.50 Contents of application.
152.55 Where to send applications and correspondence.
§ 150.17 Addresses for applications and
correspondence.
The official addresses for all submissions directed to the Office of Pesticide
Programs (OPP) of the Environmental
Protection Agency are as follows:
(a) United States Postal Service mailing
address. Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington
DC 20460–0001.
(b) Hand/courier delivery address. Office of Pesticide Programs, Environmental Protection Agency, 2777 S.
Crystal Dr., Arlington, VA 22202–4501.
(c) OPP Regulatory Public Docket address. OPP Regulatory Public Docket is
physically located in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA 22202–4501.
This is not a mailing address.
Subpart D [Reserved]
Subpart E—Procedures To Ensure
Protection of Data Submitters’ Rights
152.80 General.
152.81 Applicability.
152.83 Definitions.
152.84 When materials must be submitted to
the Agency.
152.85 Formulators’ exemption.
152.86 The cite-all method.
152.90 The selective method.
152.91 Waiver of a data requirement.
152.92 Submission of a new valid study.
152.93 Citation of a previously submitted
valid study.
152.94 Citation of a public literature study
or study generated at government expense.
152.95 Citation of all studies in the Agency’s
files pertinent to a specific data requirement.
152.96 Documentation of a data gap.
152.97 Rights and obligations of data submitters.
152.98 Procedures for transfer of exclusive
use or compensation rights to another
person.
152.99 Petitions to cancel registration.
[71 FR 35545, June 21, 2006]
PART 151 [RESERVED]
PART 152—PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES
Subpart A—General Provisions
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Sec.
152.1 Scope.
152.3 Definitions.
152.5 Pests.
152.6 Substances excluded from regulation
by FIFRA.
152.8 Products that are not pesticides because they are not for use against pests.
152.10 Products that are not pesticides because they are not intended for a pesticidal purpose.
152.15 Pesticide products required to be registered.
Subpart F—Agency Review of Applications
152.100 Scope.
152.102 Publication.
152.104 Completeness of applications.
152.105 Incomplete applications.
152.107 Review of data.
152.108 Review of labeling.
152.110 Time for agency review.
152.111 Choice of standards for review of applications.
152.112 Approval of registration under
FIFRA sec. 3(c)(5).
152.113 Approval of registration under
FIFRA sec. 3(c)(7)—Products that do not
contain a new active ingredient.
Subpart B—Exemptions
152.20 Exemptions for pesticides adequately
regulated by another Federal agency.
152.25 Exemptions for pesticides of a character not requiring FIFRA regulation.
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§ 152.1
40 CFR Ch. I (7–1–11 Edition)
152.114 Approval of registration under
FIFRA sec. 3(c)(7)—Products that contain a new active ingredient.
152.115 Conditions of registration.
152.116 Notice of intent to register to original submitters of exclusive use data.
152.117 Notification to applicant.
152.118 Denial of application.
152.119 Availability of material submitted
in support of registration.
Subpart A—General Provisions
SOURCE: 53 FR 15975, May 4, 1988, unless
otherwise noted.
§ 152.1 Scope.
(a) Part 152 sets forth procedures, requirements and criteria concerning the
registration of pesticide products under
FIFRA section 3, including plant-incorporated protectants (PIPs). Unless specifically superseded by part 174, the
regulations in part 152 apply to PIPs.
(b) Part 152 also describes associated
regulatory activities affecting registration, as described in this paragraph.
(1) Data compensation and exclusive
use of data in support of registration.
Refer to subpart E of this part.
(2) Rights and obligations of registrants.
Refer to subpart G of this part.
(3) Classification of pesticide uses.
Refer to subpart I of this part.
(4) Fees. Refer to subpart U of this
part.
(5) Requirements pertaining to pesticide
devices. Refer to subpart Z of this part.
Subpart G—Obligations and Rights of
Registrants
152.122 Currency of address of record and
authorized agent.
152.125 Submission of information pertaining to adverse effects.
152.130 Distribution under approved labeling.
152.132 Supplemental distribution.
152.135 Transfer of registration.
Subpart H [Reserved]
Subpart I—Classification of Pesticides
152.160 Scope.
152.161 Definitions.
152.164 Classification procedures.
152.166 Labeling of restricted use products.
152.167 Distribution and sale of restricted
use products.
152.168 Advertising of restricted use products.
152.170 Criteria for restriction to use by certified applicators.
152.171 Restrictions other than those relating to use by certified applicators.
152.175 Pesticides classified for restricted
use.
[73 FR 75594, Dec. 12, 2008]
§ 152.3 Definitions.
Terms used in this part have the
same meaning as in the Act. In addition, the following terms have the
meanings set forth in this section.
Act or FIFRA means the Federal Insecticide, Fungicide, and Rodenticide
Act, as amended (7 U.S.C. 136–136y).
Active ingredient means any substance
(or group of structurally similar substances if specified by the Agency) that
will prevent, destroy, repel or mitigate
any pest, or that functions as a plant
regulator, desiccant, or defoliant within the meaning of FIFRA sec. 2(a), except as provided in § 174.3 of this chapter.
Acute dermal LD50 means a statistically derived estimate of the single
dermal dose of a substance that would
cause 50 percent mortality to the test
population under specified conditions.
Acute inhalation LC50 means a statistically derived estimate of the concentration of a substance that would
cause 50 percent mortality to the test
population under specified conditions.
Acute oral LD50 means a statistically
derived estimate of the single oral dose
Subparts J–T [Reserved]
Subpart U—Registration Fees
152.400 Purpose.
152.401 Inapplicability of fee provisions to
applications filed prior to October 1, 1997.
152.403 Definitions of fee categories.
152.404 Fee amounts.
152.406 Submission of supplementary data.
152.408 Special considerations.
152.410 Adjustment of fees.
152.412 Waivers and refunds.
152.414 Procedures.
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Subparts V–Y [Reserved]
Subpart Z—Devices
152.500
Requirements for devices.
AUTHORITY: 7 U.S.C. 136–136y; Subpart U is
also issued under 31 U.S.C. 9701.
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Environmental Protection Agency
§ 152.3
of a substance that would cause 50 percent mortality to the test population
under specified conditions.
Administrator means the Administrator of the United States Environmental Protection Agency or his delegate.
Agency means the United States Environmental Protection Agency (EPA),
unless otherwise specified.
Applicant means a person who applies
for a registration or amended registration under FIFRA sec. 3.
Biological control agent means any living organism applied to or introduced
into the environment that is intended
to function as a pesticide against another organism declared to be a pest by
the Administrator.
Distribute or sell and other grammatical variations of the term such as
‘‘distributed or sold’’ and ‘‘distribution
or sale,’’ means the acts of distributing, selling, offering for sale, holding
for sale, shipping, holding for shipment, delivering for shipment, or receiving and (having so received) delivering or offering to deliver, or releasing for shipment to any person in any
State.
End use product means a pesticide
product whose labeling
(1) Includes directions for use of the
product (as distributed or sold, or after
combination by the user with other
substances) for controlling pests or defoliating, desiccating, or regulating the
growth of plants, and
(2) Does not state that the product
may be used to manufacture or formulate other pesticide products.
Final printed labeling means the label
or labeling of the product when distributed or sold. Final printed labeling
does not include the package of the
product, unless the labeling is an integral part of the package.
Inert ingredient means any substance
(or group of structurally similar substances if designated by the Agency),
other than an active ingredient, which
is intentionally included in a pesticide
product, except as provided by § 174.3 of
this chapter.
Institutional use means any application of a pesticide in or around any
property or facility that functions to
provide a service to the general public
or to public or private organizations,
including but not limited to:
(1) Hospitals and nursing homes.
(2) Schools other than preschools and
day care facilities.
(3) Museums and libraries.
(4) Sports facilities.
(5) Office buildings.
Living plant means a plant, plant
organ, or plant part that is alive, viable, or dormant. Examples of plant
parts include, but are not limited to,
seeds, fruits, leaves, roots, stems, flowers, and pollen.
Manufacturing use product means any
pesticide product that is not an end-use
product.
New use, when used with respect to a
product containing a particular active
ingredient, means:
(1) Any proposed use pattern that
would require the establishment of, the
increase in, or the exemption from the
requirement of a tolerance or food additive regulation under section 408 of
the Federal Food, Drug and Cosmetic
Act;
(2) Any aquatic, terrestrial, outdoor,
or forestry use pattern, if no product
containing the active ingredient is currently registered for that use pattern;
or
(3) Any additional use pattern that
would result in a significant increase
in the level of exposure, or a change in
the route of exposure, to the active ingredient of man or other organisms.
Operated by the same producer, when
used with respect to two establishments, means that each such establishment is either owned by, or leased for
operation by and under the control of,
the same person. The term does not include establishments owned or operated by different persons, regardless of
contractural agreement between such
persons.
Package or packaging means the immediate container or wrapping, including any attached closure(s), in which
the pesticide is contained for distribution, sale, consumption, use, or storage. The term does not include any
shipping or bulk container used for
transporting or delivering the pesticide
unless it is the only such package.
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§ 152.5
40 CFR Ch. I (7–1–11 Edition)
Pesticide means any substance or
mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as
a plant regulator, defoliant, or desiccant, other than any article that:
(1) Is a new animal drug under
FFDCA sec. 201(w), or
(2) Is an animal drug that has been
determined by regulation of the Secretary of Health and Human Services
not to be a new animal drug, or
(3) Is an animal feed under FFDCA
sec. 201(x) that bears or contains any
substances described by paragraph (s)
(1) or (2) of this section.
Pesticide product means a pesticide in
the particular form (including composition, packaging, and labeling) in
which the pesticide is, or is intended to
be, distributed or sold. The term includes any physical apparatus used to
deliver or apply the pesticide if distributed or sold with the pesticide.
Plant-incorporated protectant means a
pesticidal substance that is intended to
be produced and used in a living plant,
or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It
also includes any inert ingredient contained in the plant, or produce thereof.
Released for shipment. A product becomes released for shipment when the
producer has packaged and labeled it in
the manner in which it will be distributed or sold, or has stored it in an area
where finished products are ordinarily
held for shipment. Products stored in
an area where finished products are ordinarily held for shipment, but which
are not intended to be released for
shipment must be physically separated
and marked as not yet released for
shipment. Once a product becomes released for shipment, the product remains in the condition of being released for shipment unless subsequent
activities, such as relabeling or repackaging, constitute production.
Residential use means use of a pesticide directly:
(1) On humans or pets,
(2) In, on, or around any structure,
vehicle, article, surface, or area associated with the household, including but
not limited to areas such as non-agricultural outbuildings, non-commercial
greenhouses, pleasure boats and recreational vehicles, or
(3) In any preschool or day care facility.
[53 FR 15975, May 4, 1988, as amended at 66
FR 37814, July 19, 2001; 73 FR 64224, Oct. 29,
2008; 73 FR 75594, Dec. 12, 2008]
§ 152.5
Pests.
An organism is declared to be a pest
under circumstances that make it deleterious to man or the environment, if
it is:
(a) Any vertebrate animal other than
man;
(b) Any invertebrate animal, including but not limited to, any insect,
other arthropod, nematode, or mollusk
such as a slug and snail, but excluding
any internal parasite of living man or
other living animals;
(c) Any plant growing where not
wanted, including any moss, alga, liverwort, or other plant of any higher
order, and any plant part such as a
root; or
(d) Any fungus, bacterium, virus, or
other microorganism, except for those
on or in living man or other living animals and those on or in processed food
or processed animal feed, beverages,
drugs (as defined in FFDCA sec.
201(g)(1)) and cosmetics (as defined in
FFDCA sec. 201(i)).
§ 152.6 Substances excluded from regulation by FIFRA.
Products and substances listed in
this section are excluded from FIFRA
regulation if they meet the specified
conditions or criteria.
(a) Liquid chemical sterilants. A liquid
chemical sterilant product is not a pesticide under section 2(u) of FIFRA if it
meets all of the following criteria. Excluded products are regulated by the
Food and Drug Administration (FDA).
Products excluded are those meeting
all of the following criteria:
(1) Composition. The product must be
in liquid form as sold or distributed.
Pressurized gases or products in dry or
semi-solid form are not excluded by
this provision. Ethylene oxide products
are not liquid products and are not excluded by this provision.
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Environmental Protection Agency
§ 152.6
(2) Claims. The product must bear a
sterilant claim, or a sterilant plus subordinate level disinfection claim. Products that bear antimicrobial claims
solely at a level less than ‘‘sterilant’’
are not excluded and are jointly regulated by EPA and FDA.
(3) Use site. (i) The product must be
intended and labeled only for use on
‘‘critical or semi-critical devices.’’ A
‘‘critical device’’ is any device which is
introduced directly into the human
body, either into or in contact with the
bloodstream or normally sterile areas
of the body. A semi-critical device is any
device which contacts intact mucous
membranes but which does not ordinarily penetrate the blood barrier or
otherwise enter normally sterile areas
of the body.
(ii) Liquid chemical sterilants that
bear claims solely for use on non-critical medical devices are jointly regulated by EPA and FDA.
(iii) Liquid chemical sterilants that
bear claims solely for use on sites that
are not medical devices, such as veterinary equipment, are not excluded and
are regulated solely by EPA.
(b) Nitrogen stabilizers. A nitrogen stabilizer is excluded from regulation
under FIFRA if it is a substance (or
mixture of substances), meeting all of
the following criteria:
(1) The substance prevents or hinders
the
process
of
nitrification,
denitrification, ammonia volatilization, or urease production through action affecting soil bacteria and is distributed and sold solely for those purposes and no other pesticidal purposes.
For purposes of this section, living organisms are not considered to be substances, and the actions of living organisms are not relevant to whether a
substance is deemed to be a nitrogen
stabilizer.
(2) The substance was in ‘‘commercial agronomic use’’ in the United
States before January 1, 1992. EPA considers a substance to be in commercial
agronomic use if it is available for sale
or distribution to users for direct agronomic benefit, as opposed to limited research, experimental or demonstration
use.
(3) The substance was not registered
under FIFRA before January 1, 1992.
(4) Since January 1, 1992, the distributor or seller has made no claim
that the product prevents or hinders
the
process
of
nitrification,
denitrification, ammonia volatilization
or urease production. EPA considers
any of the following claims (or their
equivalents) to be a claim that the
product prevents or hinders nitrification, denitrification, ammonia volatilization or urease production:
(i) Improves crop utilization of applied nitrogen.
(ii) Reduces leaching of applied nitrogen or reduces groundwater nitrogen
contamination.
(iii) Prevents nitrogen loss.
(iv) Prolongs availability of nitrogen.
(v) Increases nitrogen uptake, availability, usage, or efficiency.
(5) A product will be considered to
have met the criterion of paragraph
(b)(4) of this section that no nitrogen
stabilization claim has been made if:
(i) The nitrogen stabilization claim,
in whatever terms expressed, is made
solely in compliance with a State requirement to include the claim in materials required to be submitted to a
State legislative or regulatory authority, or in the labeling or other literature accompanying the product; and
(ii) The State requirement to include
the claim was in effect both before the
product bearing the claim was introduced into commercial agronomic use,
and before the effective date of this
rule.
(6) A product that meets all of the
criteria of this paragraph with respect
to one State is not thereby excluded
from FIFRA regulation if distributed
and sold in another State whose nitrogen stabilization statement requirement does not meet the requirements
of paragraph (b)(5)(ii) of this section.
(c) Human drugs. Fungi, bacteria, viruses or other microorganisms in or on
living man are not ‘‘pests’’ as defined
in section 2(t) of FIFRA. Products intended and labeled for use against such
organisms are human drugs subject to
regulation by the FDA under the
FFDCA.
(d) Animal drugs. (1) Fungi, viruses,
bacteria or other microorganisms on or
in living animals are not ‘‘pests’’ under
section 2(t) of FIFRA. Products intended for use against such organisms
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§ 152.8
40 CFR Ch. I (7–1–11 Edition)
are ‘‘animal drugs’’ regulated by the
FDA under the FFDCA.
(2) A ‘‘new animal drug’’ as defined in
section 201(w) of the FFDCA, or an animal drug that FDA has determined is
not a ‘‘new animal drug’’ is not a pesticide under section 2(u) of FIFRA.
Animal drugs are regulated by the FDA
under the FFDCA.
(e) Animal feeds. An animal feed containing a new animal drug is not a pesticide under section 2(u) of FIFRA. An
animal feed containing a new animal
drug is subject to regulation by the
FDA under the FFDCA.
(f) Vitamin hormone products. A product consisting of a mixture of plant
hormones, plant nutrients, inoculants,
or soil amendments is not a ‘‘plant regulator’’ under section 2(v) of FIFRA,
provided it meets the following criteria:
(1) The product, in the undiluted
package concentration at which it is
distributed or sold, meets the criteria
of § 156.62 of this chapter for Toxicity
Category III or IV; and
(2) The product is not intended for
use on food crop sites, and is labeled
accordingly.
(g) Products intended to aid the growth
of desirable plants. A product of any of
the following types, intended only to
aid the growth of desirable plants, is
not a ‘‘plant regulator’’ under section
2(v) of FIFRA, and therefore is not a
pesticide:
(1) A plant nutrient product, consisting of one or more macronutrients
or micronutrient trace elements necessary to normal growth of plants and
in a form readily usable by plants.
(2) A plant inoculant product consisting of microorganisms to be applied
to the plant or soil for the purpose of
enhancing the availability or uptake of
plant nutrients through the root system.
(3) A soil amendment product containing a substance or substances intended for the purpose of improving
soil characteristics favorable for plant
growth.
§ 152.8 Products that are not pesticides because they are not for use
against pests.
A substance or article is not a pesticide, because it is not intended for
use against ‘‘pests’’ as defined in § 152.5,
if it is:
(a) A fertilizer product not containing a pesticide.
(b) A product intended to force bees
from hives for the collection of honey
crops.
[53 FR 15975, May 4, 1988, as amended at 66
FR 64764, Dec. 14, 2001]
§ 152.10 Products that are not pesticides because they are not intended for a pesticidal purpose.
A product that is not intended to prevent, destroy, repel, or mitigate a pest,
or to defoliate, desiccate or regulate
the growth of plants, is not considered
to be a pesticide. The following types
of products or articles are not considered to be pesticides unless a pesticidal
claim is made on their labeling or in
connection with their sale and distribution:
(a) Deodorizers, bleaches, and cleaning agents;
(b) Products not containing toxicants, intended only to attract pests
for survey or detection purposes, and
labeled accordingly;
(c) Products that are intended to exclude pests only by providing a physical barrier against pest access, and
which contain no toxicants, such as
certain pruning paints to trees.
§ 152.15 Pesticide products required to
be registered.
No person may distribute or sell any
pesticide product that is not registered
under the Act, except as provided in
§§ 152.20, 152.25, and 152.30. A pesticide is
any substance (or mixture of substances) intended for a pesticidal purpose, i.e., use for the purpose of preventing, destroying, repelling, or mitigating any pest or use as a plant regulator, defoliant, or desiccant. A substance is considered to be intended for
a pesticidal purpose, and thus to be a
pesticide requiring registration, if:
(a) The person who distributes or
sells the substance claims, states, or
implies (by labeling or otherwise):
[66 FR 64763, Dec. 14, 2001, as amended at 73
FR 75594, Dec. 12, 2008]
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Environmental Protection Agency
§ 152.25
(1) That the substance (either by
itself or in combination with any other
substance) can or should be used as a
pesticide; or
(2) That the substance consists of or
contains an active ingredient and that
it can be used to manufacture a pesticide; or
(b) The substance consists of or contains one or more active ingredients
and has no significant commercially
valuable use as distributed or sold
other than (1) use for pesticidal purpose (by itself or in combination with
any other substance), (2) use for manufacture of a pesticide; or
(c) The person who distributes or
sells the substance has actual or constructive knowledge that the substance
will be used, or is intended to be used,
for a pesticidal purpose.
(ii) A procaryotic microorganism including, but not limited to, Eubacteria
and Archaebacteria; or
(iii) A parasitically-replicating microscopic element, including, but not
limited to, viruses.
(4) All living plants intended for use
as biological control agents are exempt
from the requirements of FIFRA. However, plant-incorporated protectants
are not exempt pursuant to this section. Regulations, including exemptions,
for
plant-incorporated
protectants are addressed in part 174 of
this chapter.
(b) Non-liquid chemical sterilants. A
non-liquid chemical sterilant, except
ethylene oxide, that meets the criteria
of § 152.6(a)(2) with respect to its claims
and § 152.6(a)(3) with respect to its use
sites is exempted from regulation
under FIFRA.
Subpart B—Exemptions
[53 FR 15977, May 4, 1988, as amended at 66
FR 37814, July 19, 2001; 66 FR 64764, Dec. 14,
2001; 72 FR 61027, Oct. 26, 2007]
SOURCE: 53 FR 15977, May 4, 1988, unless
otherwise noted.
§ 152.25 Exemptions for pesticides of a
character not requiring FIFRA regulation.
The pesticides or classes of pesticides
listed in this section have been determined to be of a character not requiring regulation under FIFRA, and are
therefore exempt from all provisions of
FIFRA when intended for use, and
used, only in the manner specified.
(a) Treated articles or substances. An
article or substance treated with, or
containing, a pesticide to protect the
article or substance itself (for example,
paint treated with a pesticide to protect the paint coating, or wood products treated to protect the wood
against insect or fungus infestation), if
the pesticide is registered for such use.
(b) Pheromones and pheromone traps.
Pheromones and identical or substantially similar compounds labeled for
use only in pheromone traps (or labeled
for use in a manner which the Administrator determines poses no greater risk
of adverse effects on the environment
than use in pheromone traps), and
pheromone traps in which those compounds are the sole active ingredient(s).
(1) For the purposes of this paragraph, a pheromone is a compound produced by an arthropod which, alone or
wreier-aviles on DSK7SPTVN1PROD with CFR
§ 152.20 Exemptions for pesticides adequately regulated by another Federal agency.
The pesticides or classes of pesticide
listed in this section are exempt from
all requirements of FIFRA. The Agency has determined, in accordance with
FIFRA sec. 25(b)(1), that they are adequately regulated by another Federal
agency.
(a) Certain biological control agents. (1)
Except as provided by paragraphs (a)(3)
and (a)(4) of this section, all biological
control agents are exempt from FIFRA
requirements.
(2) If the Agency determines that an
individual biological control agent or
class of biological control agents is no
longer adequately regulated by another
Federal agency, and that it should not
otherwise be exempted from the requirements of FIFRA, the Agency will
revoke this exemption by amending
paragraph (a)(3) of this section.
(3) The following biological control
agents are not exempt from FIFRA requirements:
(i) A eucaryotic microorganism including, but not limited to, protozoa,
algae and fungi;
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40 CFR Ch. I (7–1–11 Edition)
in combination with other such compounds, modifies the behavior of other
individuals of the same species.
(2) For the purposes of this paragraph, a synthetically produced compound is identical to a pheromone only
when their molecular structures are
identical, or when the only differences
between the molecular structures are
between the stereochemical isomer ratios of the two compounds, except that
a synthetic compound found to have
toxicological properties significantly
different from a pheromone is not identical.
(3) When a compound possesses many
characteristics of a pheromone but
does not meet the criteria in paragraph
(a)(2) of this section, it may, after review by the Agency, be deemed a substantially similar compound.
(4) For the purposes of this paragraph, a pheromone trap is a device
containing a pheromone or an identical
or substantially similar compound used
for the sole purpose of attracting, and
trapping or killing, target arthropods.
Pheromone traps are intended to
achieve pest control by removal of target organisms from their natural environment and do not result in increased
levels of pheromones or identical or
substantially similar compounds over a
significant fraction of the treated area.
(c) Preservatives for biological specimens. (1) Embalming fluids.
(2) Products used to preserve animal
or animal organ specimens, in mortuaries, laboratories, hospitals, museums and institutions of learning.
(3) Products used to preserve the integrity of milk, urine, blood, or other
body fluids for laboratory analysis.
(d) Foods. Products consisting of
foods and containing no active ingredients, which are used to attract pests.
(e) Natural cedar. (1) Natural cedar
blocks, chips, shavings, balls, chests,
drawer liners, paneling, and needles
that meet all of the following criteria:
(i) The product consists totally of cedarwood or natural cedar.
(ii) The product is not treated, combined, or impregnated with any additional substance(s).
(iii) The product bears claims or directions for use solely to repel arthropods other than ticks or to retard mildew, and no additional claims are made
in sale or distribution. The labeling
must be limited to specific arthropods,
or must exclude ticks if any general
term such as ‘‘arthropods,’’ ‘‘insects,’’
‘‘bugs,’’ or any other broad inclusive
term, is used. The exemption does not
apply to natural cedar products
claimed to repel ticks.
(2) The exemption does not apply to
cedar oil, or formulated products which
contain cedar oil, other cedar extracts,
or ground cedar wood as part of a mixture.
(f) Minimum risk pesticides—(1) Exempted products. Products containing
the following active ingredients are exempt from the requirements of FIFRA,
alone or in combination with other
substances listed in this paragraph,
provided that all of the criteria of this
section are met.
Castor oil (U.S.P. or equivalent)
Cedar oil
Cinnamon and cinnamon oil
Citric acid
Citronella and citronella oil
Cloves and clove oil
Corn gluten meal
Corn oil
Cottonseed oil
Dried blood
Eugenol
Garlic and garlic oil
Geraniol
Geranium oil
Lauryl sulfate
Lemongrass oil
Linseed oil
Malic acid
Mint and mint oil
Peppermint and peppermint oil
2-Phenethyl propionate (2-phenylethyl propionate)
Potassium sorbate
Putrescent whole egg solids
Rosemary and rosemary oil
Sesame (includes ground sesame plant) and
sesame oil
Sodium chloride (common salt)
Sodium lauryl sulfate
Soybean oil
Thyme and thyme oil
White pepper
Zinc metal strips (consisting solely of zinc
metal and impurities)
(2) Permitted inerts. A pesticide product exempt under paragraph (f)(1) of
this section may only include inert ingredients listed in the most current
List 4A. This list is updated periodically. The most current list may be obtained by contacting the Registration
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Environmental Protection Agency
§ 152.30
Division at the appropriate address as
set forth in 40 CFR 150.17(a) or (b).
(3) Other conditions of exemption. All
of the following conditions must be
met for products to be exempted under
this section:
(i) Each product containing the substance must bear a label identifying
the name and percentage (by weight) of
each active ingredient and the name of
each inert ingredient.
(ii) The product must not bear claims
either to control or mitigate microorganisms that pose a threat to human
health, including but not limited to
disease transmitting bacteria or viruses, or claims to control insects or
rodents carrying specific diseases, including, but not limited to ticks that
carry Lyme disease.
(iii) The product must not include
any false and misleading labeling
statements, including those listed in 40
CFR 156.10(a)(5)(i) through (viii).
present as a result of incorporation
into the pesticide of either:
(i) A registered product; or
(ii) A pesticide that is produced by
the registrant of the final product; and
(3) The product as transferred is labeled in accordance with part 156 of
this chapter.
(c) A pesticide distributed or sold under
an experimental use permit. (1) An unregistered pesticide may be distributed or
sold in accordance with the terms of an
experimental use permit issued under
FIFRA sec. 5, if the product is labeled
in accordance with § 172.6 of this chapter.
(2) An unregistered pesticide may be
distributed or sold in accordance with
the provisions of § 172.3 of this chapter,
pertaining to use of a pesticide for
which an experimental use permit is
not required, provided the product is
labeled in accordance with part 156 of
this chapter.
(d) A pesticide transferred solely for export. An unregistered pesticide may be
transferred within the United States
solely for export if it meets the following conditions:
(1) The product is prepared and packaged according to the specifications of
the foreign purchaser; and
(2) The product is labeled in accordance with part 156 of this chapter.
(e) A pesticide distributed or sold under
an emergency exemption. An unregistered pesticide may be distributed or
sold in accordance with the terms of an
emergency exemption under FIFRA
sec. 18, if the product is labeled in accordance with part 156 of this chapter.
(f) A pesticide transferred for purposes
of disposal. An unregistered, suspended,
or cancelled pesticide may be transferred solely for disposal in accordance
with FIFRA sec. 19 or an applicable Administrator’s order. The product must
be labeled in accordance with part 156
of this chapter.
(g) Existing stocks of a formerly registered product. A cancelled or suspended pesticide may be distributed or
sold to the extent and in the manner
specified in an order issued by the Administrator concerning existing stocks
of the pecticide.
[53 FR 15977, May 4, 1988, as amended at 59
FR 2751, Jan. 19, 1994; 61 FR 8878, Mar. 6, 1996;
66 FR 64764, Dec. 14, 2001; 71 FR 35545, June
21, 2006]
wreier-aviles on DSK7SPTVN1PROD with CFR
§ 152.30 Pesticides that may be transferred, sold, or distributed without
registration.
An unregistered pesticide, or a pesticide whose registration has been cancelled or suspended, may be distributed or sold, or otherwise transferred, to the extent described by this
section.
(a) A pesticide transferred between registered establishments operated by the
same producer. An unregistered pesticide may be transferred between registered establishments operated by the
same producer. The pesticide as transferred must be labeled in accordance
with part 156 of this chapter.
(b) A pesticide transferred between registered establishments not operated by the
same producer. An unregistered pesticide may be transferred between registered establishments not operated by
the same producer if:
(1) The transfer is solely for the purpose of further formulation, packaging,
or labeling into a product that is registered;
(2) Each active ingredient in the pesticide, at the time of transfer, is
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§ 152.40
40 CFR Ch. I (7–1–11 Edition)
makes this determination, the Agency
will notify the applicant of its determination and its reasons. Thereafter
the application for an alternate formulation will be treated as an application
for new registration, and the alternate
formulation will be assigned a new registration number.
Subpart C—Registration
Procedures
SOURCE: 53 FR 15978, May 4, 1988, unless
otherwise noted.
§ 152.40 Who may apply.
Any person may apply for new registration of a pesticide product. Any
registrant may apply for amendment of
the registration of his product.
[53 FR 15978, May 4, 1988, as amended at 72
FR 61027, Oct. 26, 2007]
§ 152.44 Application for amended registration.
wreier-aviles on DSK7SPTVN1PROD with CFR
§ 152.42 Application for new registration.
Any person seeking to obtain a registration for a new pesticide product
must submit an application for registration, containing the information
specified in § 152.50. An application for
new registration must be approved by
the Agency before the product may legally be distributed or sold, except as
provided by § 152.30.
(a) Except as provided by § 152.46, any
modification in the composition, labeling, or packaging of a registered product must be submitted with an application for amended registration. The applicant must submit the information
required by § 152.50, as applicable to the
change requested. If an application for
amended registration is required, the
application must be approved by the
Agency before the product, as modified,
may legally be distributed or sold.
(b) In its discretion, the Agency may:
(1) Waive the requirement for submission of an application for amended
registration;
(2) Require that the applicant certify
to the Agency that he has complied
with an Agency directive rather than
submit an application for amended registration; or
(3) Permit an applicant to modify a
registration by notification or non-notification in accordance with § 152.46.
(c) A registrant may at any time submit identical minor labeling amendments affecting a number of products
as a single application if no data are
required for EPA to approve the
amendment (for example, a change in
the wording of a storage statement for
designated residential use products). A
consolidated application must clearly
identify the labeling modification(s) to
be made (which must be identical for
all products included in the application), list the registration number of
each product for which the modification is requested, and provide required
supporting materials (for example, labeling) for each affected product.
§ 152.43 Alternate formulations.
(a) A product proposed for registration must have a single, defined composition, except that EPA may approve
a basic formulation and one or more alternate formulations for a single product.
(b) An alternate formulation must
meet the criteria listed in paragraph
(b) (1) through (4) of this section. The
Agency may require the submission of
data to determine whether the criteria
have been met.
(1) The alternate formulation must
have the same certified limits for each
active ingredient as the basic formulation.
(2) If the alternate formulation contains an inert ingredient or impurity of
toxicological signficance, the formulation must have the same upper certified limit for that substance as the
basic formulation;
(3) The label text of the alternate formulation product must be identical to
that of the basic formulation.
(4) The analytical method required
under § 158.355 of this chapter must be
suitable for use on both the basic formulation and the alternate formulation.
(c) Notwithstanding the criteria in
this section, the Agency may determine that an alternate formulation
must be separately registered. If EPA
[53 FR 15978, May 4, 1988, as amended at 61
FR 33041, June 26, 1996; 66 FR 64764, Dec. 14,
2001]
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Environmental Protection Agency
§ 152.50
a manner inconsistent with paragraphs
(a) or (b) of this section and any procedures issued thereunder, the Agency
may initiate regulatory and/or enforcement action without first providing the
registrant with an opportunity to submit an application for amended registration.
§ 152.46 Notification and non-notification changes to registrations.
(a) Changes permitted by notification.
(1) EPA may determine that certain
minor modifications to registration
having no potential to cause unreasonable adverse effects to the environment
may be accomplished by notification to
the Agency, without requiring that the
registrant obtain Agency approval. If
EPA so determines, it will issue procedures following an opportunity for public comment describing the types of
modifications permitted by notification and any conditions and procedures
for submitting notifications.
(2) A registrant may modify a registration consistent with paragraph
(a)(1) of this section and any procedures issued thereunder and distribute
or sell the modified product as soon as
the Agency has received the notification. Based upon the notification, the
Agency may require that the registrant submit an application for
amended registration. If it does so, the
Agency will notify the registrant and
state its reasons for requiring an application
for
amended
registration.
Thereafter, if the registrant fails to
submit an application the Agency may
determine that the product is not in
compliance with the requirements of
the Act. Notification under this paragraph is considered a report filed under
the Act for the purposes of FIFRA section 12(a)(2)(M).
(b) Changes permitted without notification. EPA may determine that certain
minor modifications to registration
having no potential to cause unreasonable adverse effects to the environment
may be accomplished without notification to or approval by the Agency. If
EPA so determines, it will issue procedures following an opportunity for public comment describing the types of
amendments permitted without notification (also known as non-notification). A registrant may distribute or
sell a product changed in a manner
consistent with such procedures without notification to or approval by the
Agency.
(c) Effect of non-compliance. Notwithstanding any other provision of this
section, if the Agency determines that
a product has been modified through
notification or without notification in
[61 FR 33041, June 26, 1996]
§ 152.50 Contents of application.
Each application for registration or
amended registration must include the
following information, as applicable:
(a) Application form. An application
form must be completed and submitted
to the Agency. Application forms are
provided by the Agency, with instructions as to the number of copies required and proper completion.
(b) Identity of the applicant—(1) Name.
The applicant must identify himself.
An applicant not residing in the United
States must also designate an agent in
accordance with paragraph (b)(3) of
this section to act on behalf of the applicant on all registration matters.
(2) Address of record. The applicant
must provide an address in the United
States for correspondence purposes.
The U.S. address provided will be considered the applicant’s address of
record, and EPA will send all correspondence concerning the application
and any subsequent registration to
that address. It is the responsibility of
the applicant and any registrant under
§ 152.122 to ensure that the Agency has
a current and accurate address.
(3) Authorized agent. An applicant
may designate a person residing in the
United States to act as his agent. If an
applicant wishes to designate an agent,
he must send the Agency a letter stating the name and United States address of his agent. The applicant must
notify the Agency if he changes his
designated agent. This relationship
may be terminated at any time by the
applicant by notifying the Agency in
writing.
(4) Company number. If an applicant
has been assigned a company number
by the Agency, the application must
reference that number.
(c) Summary of the application. Each
application must include a list of the
data submitted with the application,
together with a brief description of the
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§ 152.50
40 CFR Ch. I (7–1–11 Edition)
results of the studies. The list of data
submitted may be the same as the list
required by § 158.32 or § 161.32, as applicable, of this chapter. The summary
must state that it is releasable to the
public after registration in accordance
with § 152.119.
(d) Identity of the product. The product for which application is being submitted must be identified. The following information is required:
(1) The product name;
(2) The trade name(s) (if different);
and
(3) The EPA Registration Number, if
currently registered.
(e) Draft labeling. Each application
for new registration must be accompanied by five legible copies of draft labeling (typescript or mock-up). Each
application for amended registration
that proposes to make any changes in
the product labeling must be accompanied by five legible copies of draft labeling incorporating the proposed labeling changes. If the proposed labeling
change affects only a portion of the labeling, such as the use directions, the
applicant may submit five copies of
that portion of the label which is the
subject of the amendment. Upon request, an applicant for amended registration must submit a complete label
to consolidate amendments.
(f) Registration data requirements. (1)
An applicant must submit materials to
demonstrate that he has complied with
the FIFRA sec. 3(c)(1)(F) and subpart E
of this part with respect to satisfaction
of data requirements, to enable the
Agency to make the determination required by FIFRA sec. 3(c)(5)(B). Required items are described in subpart E
of this part.
(2) An applicant must furnish any
data specified in part 158 or part 161 of
this chapter, as applicable, of this
chapter which are required by the
Agency to determine that the product
meets the registration standards of
FIFRA sec. 3(c)(5) or (7). Each study
must comply with:
(i) Section 158.32 of this chapter, with
respect to format of data submission.
(ii) Section 158.33 of this chapter,
with respect to studies for which a
claim of trade secret or confidential
business information is made.
(iii) Section 158.34 of this chapter,
with respect to flagging for potential
adverse effects.
(iv) Section 160.12 of this chapter,
with respect to a statement whether
studies were conducted in accordance
with Good Laboratory Practices of part
160.
(3) An applicant shall furnish with
his application any factual information
of which he is aware regarding unreasonable adverse effects of the pesticide
on man or the environment, which
would be required to be reported under
FIFRA sec. 6(a)(2) if the product were
registered.
(g) Certification relating to child-resistant packaging. If the product meets the
criteria for child-resistant packaging,
the applicant must submit a certification that the product will be distributed or sold only in child-resistant
packaging. Refer to part 157 of this
chapter for the criteria and certification requirements.
(h) Request for classification. If an applicant wishes to request a classification different from that established by
the Agency, he must submit a request
for such classification and information
supporting the request.
(i) Statement concerning tolerances. (1)
If the proposed labeling bears instructions for use of the pesticide on food or
feed crops, or if the intended use of the
pesticide results or may be expected to
result, directly or indirectly, in pesticide chemical residues in or on food
or feed (including residues of any active ingredient, inert ingredient, metabolite, or degradation product), the
applicant must submit a statement indicating whether such residues are authorized by a tolerance or exemption
from the requirement of a tolerance
issued under section 408 of the Federal
Food, Drug and Cosmetic Act (FFDCA).
(2) If such residues have not been authorized, the application must be accompanied by a petition for establishment of appropriate tolerances or exemptions from the requirement of a
tolerance, in accordance with part 180
of this chapter.
(j) Fees. (1) The applicant shall identify the appropriate fee category in the
schedule provided for by FIFRA sec. 33,
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Environmental Protection Agency
§ 152.81
and shall submit the fee for that category as prescribed by the latest EPA
notice of section 33 fees.
(2) If FIFRA sec. 33 is not in effect,
the applicant shall submit any fees required by subpart U of this part, if applicable.
§ 152.81
[53 FR 15978, May 4, 1988, as amended at 58
FR 34203, June 23, 1993; 60 FR 32096, June 19,
1995; 72 FR 61027, Oct, 26 2007; 73 FR 75594,
Dec. 12, 2008]
§ 152.55 Where to send applications
and correspondence.
Applications and correspondence relating to registration should be sent to
the Office of Pesticide Programs’ Document Processing Desk at the appropriate address as set forth in 40 CFR
150.17(a) or (b).
[71 FR 35545, June 21, 2006]
Subpart D [Reserved]
Subpart E—Procedures To Ensure
Protection of Data Submitters’
Rights
SOURCE: 49 FR 30903, Aug. 1, 1984, unless
otherwise noted.
wreier-aviles on DSK7SPTVN1PROD with CFR
§ 152.80
Applicability.
(a) Except as provided in paragraph
(b) of this section, §§ 152.83 through
152.119 apply to:
(1) Each application for registration
of a new product;
(2) Each application for an amendment of a registration; and
(3) Each application for reregistration under FIFRA section 3(g).
(b) This subpart E does not apply to:
(1) Applications for registration submitted to States under FIFRA section
24(c);
(2) Applications for experimental use
permits under FIFRA section 5;
(3) Applications for emergency exemptions under FIFRA section 18;
(4) Applications to make only one or
more of the following types of amendments to existing registrations, unless
the Administrator or his designee finds
that Agency consideration of scientific
data would be necessary in order to approve the amendment under FIFRA
section 3(c)(5):
(i) An increase or decrease in the percentage in the product of one or more
of its active ingredients or deliberately
added inert ingredients;
(ii) A revision of the identity or
amount of impurities present in the
product;
(iii) The addition or deletion of one
or more deliberately added inert ingredients;
(iv) The deletion of one or more active ingredients;
(v) A change in the source of supply
of one or more of the active ingredients
used in the product, if the new source
of the active ingredient is a product
which is registered under FIFRA section 3;
(vi) Deletion of approved uses of
claims;
(vii) Redesign of the label format involving no substantive changes, express or implied, in the directions for
use, claims, representations, or precautionary statements;
(viii) Change in the product name or
addition of an additional brand name,
if no additional claims, representations, or uses are expressed or implied
by the changes;
(ix) Clarification of directions for
use;
General.
This subpart E describes the information that an applicant must submit
with his application for registration or
amended registration to comply (and
for the Agency to determine compliance) with the provisions of FIFRA sec.
3(c)(1)(F). This subpart also describes
the procedures by which data submitters may challenge registration actions
which allegedly failed to comply with
these procedures. If the Agency determines that an applicant has failed to
comply with the requirements and procedures in this subpart, the application
may be denied. If the Agency determines, after registration has been
issued, that an applicant failed to comply with these procedures and requirements, the Agency may issue a notice
of intent to cancel the product’s registration.
[73 FR 75594, Dec. 12, 2008]
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§ 152.83
40 CFR Ch. I (7–1–11 Edition)
wreier-aviles on DSK7SPTVN1PROD with CFR
(x) Correction of typographical errors;
(xi) Changes in the registrant’s name
or address;
(xii) Adding or deleting supplemental
registrants;
(xiii) Changes in the package or container size;
(xiv) Changes in warranty, warranty
disclaimer, or liability limitation
statements, or addition to or deletion
of such statements;
(xv) ‘‘Splitting’’ a label for the sole
purpose of facilitating the marketing
of a product in different geographic regions with appropriate labels, where
each amended label will contain previously approved use instructions (and
related label statements) appropriate
to a particular geographic region;
(xvi) Any other type of amendment,
if the Administrator or his designee determines, by written finding, that the
Agency consideration of scientific data
would not be necessary in order to approve the amendment under FIFRA
section 3(c)(5); and
(xvii) Compliance with Agency Regulations, adjudicatory hearing decisions,
notices, or other Agency announcements that unless the registration is
amended in the manner the Agency
proposes, the product’s registration
will be suspended or cancelled, or that
a hearing will be held under FIFRA
section 6. (However, this paragraph
does not apply to amendments designed
to avoid cancellation or suspension
threatened
under
FIFRA
section
3(c)(2)(B) or because of failure to submit data.)
(1) The study pertains to a new active
ingredient (new chemical) or new combination of active ingredients (new
combination) first registered after September 30, 1978;
(2) The study was submitted in support of, or as a condition of approval
of, the application resulting in the first
registration of a product containing
such new chemical or new combination
(first registration), or an application to
amend such registration to add a new
use; and
(3) The study was not submitted to
satisfy a data requirement imposed
under FIFRA section 3(c)(2)(B);
Provided that, a study is an exclusive
use study only during the 10-year period following the date of the first registration.
Original data submitter means the person who possesses all rights to exclusive use or compensation under FIFRA
section 3(c)(1)(F) in a study originally
submitted in support of an application
for registration, amended registration,
reregistration, or experimental use
permit, or to maintain an existing registration in effect. The term includes
the person who originally submitted
the study, any person to whom the
rights under FIFRA section 3(c)(1)(F)
have been transferred, or the authorized representative of a group of joint
data developers.
Valid study means a study that has
been conducted in accordance with the
Good Laboratory Practice standards of
40 CFR part 160 or generally accepted
scientific methodology and that EPA
has not determined to be invalid.
§ 152.83 Definitions.
As used in this subpart, the following
terms shall have the meanings set
forth in this section:
Data gap means the absence of any
valid study or studies in the Agency’s
files which would satisfy a specific
data requirement for a particular pesticide product.
Data Submitters List means the current Agency list, entitled ‘‘Pesticide
Data Submitters by Chemical,’’ of persons who have submitted data to the
Agency.
Exclusive use study means a study
that meets each of the following requirements:
[49 FR 30903, Aug. 1, 1984, as amended at 73
FR 75595, Dec. 12, 2008]
§ 152.84 When materials must be submitted to the Agency.
All information required by this subpart should be submitted with the application, but may be submitted at any
later time prior to EPA’s approval of
the application. The Agency will not
approve any application until it determines either that the application is not
subject to these requirements or that
all required materials have been submitted and are acceptable.
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Environmental Protection Agency
§ 152.86
whose label does not prohibit its use
for making an end-use product labeled
for any use for which the applicant’s
product will be labeled; or
(3) The purchased product is a registered end-use product labeled for
each use for which the applicant’s
product will be labeled.
(d) Claiming eligibility for the exemption. (1) If the product contains one or
more ingredients eligible for the formulators’ exemption, the applicant
need not comply with the requirements
of §§ 152.90 through 152.96 with respect
to any data requirement pertaining to
such ingredient, provided that he submits to the Agency a certification
statement containing the following information (a form for this purpose is
available from the Agency):
(i) Identification of the applicant,
and of the product by EPA registration
number or file symbol.
(ii) Identification of each ingredient
in the pesticide that is eligible for the
formulators’ exemption, and the EPA
registration number of the product
that is the source of that ingredient.
(iii) A statement that the listed ingredients meet the requirements for
the formulators’ exemption.
(iv) A statement that the applicant
has submitted (either previously or
with the current application) a complete, accurate and current Confidential Statement of Formula.
(v) The name, title and signature of
the applicant or his authorized representative and the date of signature.
(2) An applicant for amended registration is not required to submit a
new formulators’ exemption statement,
if the current statement in Agency
files is complete and accurate.
(e) Approval of registration. Notwithstanding FIFRA section 3(c)(2)(D), EPA
will not approve an application unless
there are available to EPA for its review all data that are necessary to
make the required risk/benefit finding
under FIFRA section 3(c)(5) or section
3(c)(7).
§ 152.85 Formulators’ exemption.
(a) Statutory provision. FIFRA section
3(c)(2)(D) excuses an applicant from the
requirement to submit or cite data pertaining to any pesticide contained in
his product that is derived solely from
one or more EPA-registered products
which the applicant purchases from another person. This provision is commonly referred to as the formulators’
exemption.
(b) Applicability of the formulators’ exemption. (1) The formulators’ exemption applies only to data concerning
the purchased product or its ingredients. These data may include, but are
not limited to, product chemistry,
toxicology, residue chemistry, exposure, environmental fate, and ecological effects.
(2) The data to which the formulators’ exemption applies usually will
concern the safety of one or more of
the product’s active ingredients, specifically, those active ingredients
which are contained in the purchased
product. In general, data for which the
required test substance is the technical
grade of the active ingredient, the pure
active ingredient, the radiolabeled pure
active ingredient, or a typical end-use
product are eligible for the formulators’ exemption.
(3) The formulators’ exemption generally does not apply to data on the applicant’s product itself, including the
safety or efficacy of the product, unless
the composition of the product is identical to the purchased product. In general, data for which the required test
substance is the product proposed for
registration are not eligible for the formulators’ exemption.
(c) Limitation of the formulators’ exemption. EPA interprets FIFRA section
3(c)(2)(D) as allowing an applicant to
use the formulators’ exemption with
respect to data concerning an ingredient of his product only if:
(1) The application indicates that the
ingredient’s presence in the product is
attributable solely to the purchase
from another person of an identified,
registered product containing that ingredient and the use of the purchased
product in formulating the product;
and
(2) The purchased product is a registered
manufacturing-use
product
[72 FR 61027, Oct. 26, 2007]
§ 152.86 The cite-all method.
An applicant may comply with this
subpart by citing all data in Agency
files that are pertinent to its consideration of the requested registration
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§ 152.90
40 CFR Ch. I (7–1–11 Edition)
3(c)(1)(F) of the Federal Insecticide, Fungicide and Rodenticide Act.
under FIFRA section 3(c)(5), in accordance with the procedures in this section, as applicable.
(a) Exclusive use studies. The applicant must certify to the Agency that
he has obtained, from each person listed on the Data Submitters List as an
exclusive use data submitter for the
chemical in question, a written authorization that contains at least the following information:
(1) Identification of the applicant to
whom the authorization is granted;
(2) Authorization to the applicant to
use all pertinent studies in satisfaction
of data requirements for the application in question; and
(3) The signature and title of the
original data submitter or his authorized representative and date of the authorization.
If the Agency identifies any exclusive
use data submitter not on the Data
Submitters List, the applicant will be
required prior to registration to obtain
the necessary written authorization
from such person.
(b) Other studies. The applicant must
certify to the Agency that, with respect to each other person on the Data
Submitters List for the chemical in
question:
(1) He has obtained from that person
a written authorization that contains
the information required by paragraphs
(a) (1) through (3) of this section; or
(2) He has furnished to that person:
(i) A notification of his intent to
apply for registration, including the
name of the proposed product, and a
list of the product’s active ingredients;
(ii) An offer to pay the person compensation to the extent required by
FIFRA section 3(c)(1)(F) for any data
on which the application relies;
(iii) An offer to commence negotiations to determine the amount and
terms of compensation, if any, to be
paid for the use of any study; and
(iv) His name, address and telephone
number.
(c) General offer to pay statement. The
applicant must submit to the Agency
the following general offer to pay
statement:
(d) Acknowledgement of reliance on
data. Each application filed under this
section shall include an acknowledgement that for purposes of FIFRA section 3(c)(1)(F) the application relies on
the following data:
(1) All data submitted with or specifically cited in the application; and
(2) Each other item of data in the
Agency’s files which:
(i) Concerns the properties or effects
of the applicant’s product, of any product which is identical or substantially
similar to the applicant’s product, or of
one or more of the active ingredients in
the applicant’s product; and
(ii) Is one of the types of data that
EPA would require to be submitted if
the application sought the initial registration under FIFRA section 3(c)(5) of
a product with composition and intended uses identical or substantially
similar to the applicant’s product,
under the data requirements in effect
on the date EPA approves the applicant’s present application.
[49 FR 30903, Aug. 1, 1984, as amended at 73
FR 75595, Dec. 12, 2008]
§ 152.90 The selective method.
An applicant may comply with this
subpart by listing the specific data requirements that apply to his product,
its active ingredients, and use patterns, and demonstrating his compliance for each data requirement by submitting or citing individual studies, or
by demonstrating that no study has
previously been submitted to the Agency. This section summarizes the procedures that an applicant must follow if
he chooses the selective method of
demonstrating compliance. Sections
152.91 through 152.96 contain specific
procedures for citing or submitting a
study or demonstrating a data gap.
(a) List of data requirements. Each applicant must submit a list of the data
requirements that would apply to his
pesticide, its active ingredients, and its
use patterns, if the product were being
proposed for registration under FIFRA
section 3(c)(5) for the first time. The
applicant need not list data requirements pertaining to any ingredient
which qualifies for the formulator’s exemption.
[Name of applicant] hereby offers and agrees
to pay compensation to other persons, with
regard to the approval of this application, to
the extent required by FIFRA section
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Environmental Protection Agency
§ 152.93
(1) If a Registration Standard has
been issued for any active ingredient,
the applicant must list the applicable
data requirements enumerated in that
Standard for the active ingredient and,
if end use products are covered by the
Registration Standard, for such products containing that active ingredient.
(2) If a Registration Standard has not
been issued, or if an issued Registration Standard does not cover all data
requirements for products containing
the active ingredient in question, the
applicant must list the applicable requirements as prescribed by 40 CFR
part 158 or part 161, as applicable. All
required (R) studies, and any studies
that could be conditionally required
(CR) based upon composition, use pattern, or the results of required studies,
are to be listed. The applicant may
demonstrate via the data gap procedures in § 152.96 that a conditional requirement need not be satisfied by the
submission or citation of data at the
time of application.
(b) Methods of demonstrating compliance. The applicant must state for each
data requirement on the list required
by paragraph (a) of this section which
of the following methods of compliance
with the requirement he is using, and
shall provide the supporting documentation specified in the referenced
section.
(1) Existence of or granting of a data
waiver. Refer to § 152.91.
(2) Submission of a new valid study.
Refer to § 152.92.
(3) Citation of a specific valid study
previously submitted to the Agency by
the applicant or another person, with
any necessary written authorizations
or offers to pay. Refer to § 152.93.
(4) Citation of a public literature
study. Refer to § 152.94.
(5) Citation of all pertinent studies
previously submitted to the Agency,
with any necessary written authorizations or offers to pay. Refer to § 152.95.
(6) Documentation of a data gap.
Refer to § 152.96.
accordance with paragraph (a) of this
section, or by being granted a new
waiver requested in accordance with
paragraph (b) of this section.
(a) Request for extension of an existing
waiver. An applicant may claim that a
waiver previously granted by the Agency also applies to a data requirement
for his product. To document this
claim, the applicant must provide a
reference to the Agency record that describes the previously granted waiver,
such as an Agency list of waivers or an
applicable Registration Standard, and
must explain why that waiver should
apply to his product.
(b) Request for a new waiver. An applicant who requests a waiver to satisfy a
data requirement must submit the information specified in 40 CFR 158.45 or
40 CFR 161.45.
(c) Effect of denial of waiver request. If
the request for a new waiver or extension of an existing waiver is denied by
the Agency, the applicant must choose
another method of satisfying the data
requirement.
[49 FR 30903, Aug. 1, 1984, as amended at 72
FR 61028, Oct. 26, 2007]
§ 152.92 Submission of a new valid
study.
An applicant may demonstrate compliance for a data requirement by submitting a valid study that has not previously been submitted to the Agency.
A study previously submitted to the
Agency should not be resubmitted but
should be cited in accordance with
§ 152.93.
§ 152.93 Citation of a previously submitted valid study.
An applicant may demonstrate compliance for a data requirement by citing a valid study previously submitted
to the Agency. The study is not to be
submitted to the Agency with the application.
(a) Study originally submitted by the
applicant. If the applicant certifies that
he is the original data submitter, no
documentation other than the citation
is necessary.
(b) Study previously submitted by another person. If the applicant is not the
original data submitter, the applicant
may cite the study only in accordance
wreier-aviles on DSK7SPTVN1PROD with CFR
[49 FR 30903, Aug. 1, 1984, as amended at 72
FR 61028, Oct. 26, 2007]
§ 152.91 Waiver of a data requirement.
The applicant may demonstrate compliance for a data requirement by documenting the existence of a waiver in
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§ 152.94
40 CFR Ch. I (7–1–11 Edition)
(3) Citation without authorization or
offer to pay. The applicant may cite any
valid study without written authorization from, or offer to pay to, the original data submitter if the study was
originally submitted to the Agency on
or before the date that is 15 years before the date of the application for
which it is cited, and the study is not
an exclusive use study, as defined in
§ 152.83(c).
with paragraphs (b) (1) through (3) of
this section.
(1) Citation with authorization of original data submitter. The applicant may
cite any valid study for which he has
obtained the written authorization of
the original data submitter. The applicant must obtain written authorization
to cite any study that is an exclusive
use study. The applicant must certify
that he has obtained from the original
data submitter a written authorization
that contains at least the following information:
(i) Identification of the applicant to
whom the authorization is granted;
(ii) Identification by title, EPA Accession Number or Master Record Identification Number, and date of submission, of the study or studies for which
the authorization is granted;
(iii) Authorization to the applicant
to use the specified study in satisfaction of the data requirement for the application in question; and
(iv) The signature and title of the
original data submitter or his authorized representative, and date of the authorization.
(2) Citation with offer to pay compensation to the original data submitter. The
applicant may cite any valid study
that is not subject to the exclusive use
provisions
of
FIFRA
section
3(c)(1)(F)(i) without written authorization from the original data submitter if
the applicant certifies to the Agency
that he has furnished to the original
data submitter:
(i) A notification of the applicant’s
intent to apply for registration, including the proposed product name and a
list of the product’s active ingredients;
(ii) Identification of the specific data
requirement involved and of the study
for which the offer to pay is made (by
title, EPA Accession Number or Master
Record Identification Number, and
date of submission, if possible);
(iii) An offer to pay the person compensation to the extent required by
FIFRA section 3(c)(1)(F);
(iv) An offer to commence negotiations to determine the amount and
terms of compensation, if any, to be
paid for the use of the study; and
(v) The applicant’s name, address and
telephone number.
[49 FR 30903, Aug. 1, 1984, as amended at 73
FR 75595, Dec. 12, 2008]
§ 152.94 Citation of a public literature
study or study generated at government expense.
(a) An applicant may demonstrate
compliance for a data requirement by
citing, and submitting to the Agency,
one of the following:
(1) A valid study from the public literature.
(2) A valid study generated by, or at
the expense of, any government (Federal, State, or local) agency.
(b) In no circumstances does submission of a public literature study or government-generated study confer any
rights on the data submitter to exclusive use of data or compensation under
FIFRA section 3(c)(1)(F).
[49 FR 30903, Aug. 1, 1984, as amended at 73
FR 75595, Dec. 12, 2008]
§ 152.95 Citation of all studies in the
Agency’s files pertinent to a specific
data requirement.
An applicant normally may demonstrate compliance for a data requirement by citation of all studies in the
Agency’s files pertinent of that data
requirement. The applicant who selects
this cite-all option must submit to the
Agency:
(a) A general offer to pay statement
having the same wording as that specified in § 152.86(c) except that the offer
to pay may be limited to apply only to
data pertinent to the specific data requirement(s) for which the cite-all
method of support has been selected;
(b) A certification that:
(1) For each person who is included
on the Data Submitters List as an
original data submitter of exclusive
use data for the active ingredient in
question, the applicant has obtained a
written authorization containing the
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Environmental Protection Agency
§ 152.96
registered during the limited period of
time required to complete the study.
Refer to FIFRA section 3(c)(7)(C).
(2) An applicant for registration of a
product under FIFRA section 3(c)(7) (A)
or (B) may not defer his obligation by
the procedure in this section if the
Agency requires the data to determine:
(i) Whether the product is identical
or substantially similar to another currently registered product or differs
only in ways that would not substantially increase the risk of unreasonable
adverse effects on the environment;
(ii) If efficacy data are required,
whether the product is efficacious; or
(iii) Whether the new use would substantially increase the risk of unreasonable adverse effects on the environment, usually required when the application involves a new use of a product
which is identical or substantially
similar to a currently registered product.
(b) Data gap listed in a Registration
Standard. The applicant may rely on a
data gap that is documented by a Registration Standard without submitting
the certification required by paragraph
(c) of this section. If the data gap listed
in the Registration Standard has been
filled since the issuance of the Standard, the Agency will notify the applicant and require him to choose another
method of demonstrating compliance.
(c) Certification of a data gap. Except
as provided by paragraph (b) of this
section, an applicant who wishes to
claim that a data gap exists must certify to the Agency that:
(1) The applicant has furnished, by
certified mail, to each original data
submitter on the current Data Submitters List for the active ingredient in
question, a notice containing the following information:
(i) The name and address of the applicant;
(ii) The name of the product, and a
statement that the applicant intends
to apply for registration of that product;
(iii) The name(s) of the active ingredient(s) in the procuct;
(iv) A list of the data requirements
for which the applicant intends to
claim under this section that a data
gap exists; and
information required by § 152.86(a) for
the use the any exclusive use study
that would be pertinent to the applicant’s product; and
(2) For each person included on the
current Data Submitters List as an
original data submitter of data that
are not exclusive use for the active ingredient in question, the applicant has
furnished:
(i) A notification of the applicant’s
intent to apply for registration, including the name of the proposed product,
and a list of the product’s active ingredients;
(ii) Identification of the specific data
requirement(s) for which the offer to
pay for data is being made;
(iii) An offer to pay the person compensation to the extent required by
FIFRA section 3(c)(1)(F);
(iv) An offer to commence negotiations to determine the amount and
terms of compensation, if any, to be
paid for use of any study; and
(v) The applicant’s name, address and
telephone number; and
(c) An acknowledgment having the
same wording as that specified in
§ 152.86(d), except that it may be limited to apply only to data pertinent to
the specific data requirement(s) for
which the cite-all method of support
has been selected.
wreier-aviles on DSK7SPTVN1PROD with CFR
[49 FR 30903, Aug. 1, 1984, as amended at 73
FR 75595, Dec. 12, 2008]
§ 152.96 Documentation of a data gap.
Except as provided in paragraph (a)
of this section, an applicant may defer
his obligation to satisfy an applicable
data requirement until the Agency requests the data if he can demonstrate,
by the procedure in this section, that
no other person has previously submitted to the Agency a study that
would satisfy the data requirement in
question.
(a) When data gap procedures may not
be used. (1) An applicant for registration of a product containing a new
chemical may not defer his obligation
by the procedure in this section, unless
he can demonstrate to the Agency’s
satisfaction that the data requirement
was imposed so recently that insufficient time has elapsed for the study to
have been completed and that, in the
public interest, the product should be
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§ 152.97
40 CFR Ch. I (7–1–11 Edition)
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(v) A request that the data submitter
identify, within 60 days of receipt of
the notice, any valid study which he
has submitted to the Agency that
would fulfill any of the data requirement(s) listed.
(2) The applicant has, within that 60day period, received no response, or has
received a negative response, from each
person notified; and
(3) The applicant has no basis to believe that any data have been submitted to the Agency that would fulfill
the data requirement, and is entitled
to claim that a data gap exists.
(d) Requirement to obtain permission or
make offer to pay. In responding to a
data gap letter, the original data submitter is not deemed to have given his
authorization for the applicant to cite
any study which the data submitter
identifies in his response. The applicant must seek and obtain specific
written authorization from, or make
an offer to pay to, the original data
submitter to cite the identified study
in order to demonstrate compliance for
the data requirement. Nothing, however, precludes the applicant from requesting written authorization or making an offer to pay at the same time
that he requests confirmation of a data
gap.
(3) Each applicant not already included on the Data Submitters List for
a particular active ingredient must inform the Agency at the time of submission of a relevant study whether he
wishes to be included on the Data Submitters List for that pesticide.
(b) Obligation to respond to data gap
letters. An applicant who chooses to
defer his obligation by demonstrating
the existence of a data gap must write
to each original data submitter for
confirmation that the data submitter
has not submitted a valid study that
would satisfy the requirement. The
original data submitter is not required
to respond to such letters. However, if
he fails to respond, the applicant is entitled to assume (and the Agency will
act on the assumption) that the original data submitter has not submitted a
study to satisfy the requirement. The
data submitter may thereby limit his
right to later challenge the applicant’s
claim if he fails respond in writing delivered to the applicant within 60 days
of receipt of the applicant’s data gap
letter.
[49 FR 30903, Aug. 1, 1984, as amended at 72
FR 61028, Oct. 26, 2007]
§ 152.98 Procedures for transfer of exclusive use or compensation rights
to another person.
A person who possesses rights to exclusive use or compensation under
FIFRA section 3(c)(1)(F) may transfer
such rights to another person in accordance with this section.
(a) The original data submitter must
submit to the Agency a transfer document that contains the following information:
(1) The name, address and state of incorporation (if any) of the original data
submitter (the transferor);
(2) The name, address and state of incorporation (if any) of the person to
whom the data rights are being transferred (the transferee);
(3) Identification of each item of data
transferred including:
(i) The name of the study or item of
data;
(ii) Whether the study is an exclusive
use study, and, if so, when the period of
exclusive use protection expires;
(iii) The name of the person or laboratory that conducted the study;
§ 152.97 Rights and obligations of data
submitters.
(a) Right to be listed on Data Submitters
List. (1) Each original data submitter
shall have the right to be included on
the Agency’s Data Submitters List.
(2) Each original data submitter who
wishes to have his name added to the
current Data Submitters List must
submit to the Agency the following information:
(i) Name and current address;
(ii) Chemical name and common
name (if any) of the active ingredient(s), with respect to which he is an
original data submitter;
(iii) For each such active ingredient,
the type(s) of study he has previously
submitted (corresponding to Guidelines
reference numbers given in tables in 40
CFR part 158 or part 161, as applicable),
the date of submission, and the EPA
registration number, file symbol, or
other identifying reference for which it
was submitted.
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Environmental Protection Agency
§ 152.99
that an applicant purportedly has
failed to satisfy.
(a) Grounds for petition. (1) If an applicant has offered to pay compensation
to an original data submitter of a
study (either specifically or by filing a
general offer to pay statement), the
original data submitter may petition
the Agency to deny or cancel the registration to which the offer related on
any of the following grounds:
(i) The applicant has failed to participate in an agreed-upon procedure
for reaching an agreement on the
amount and terms of compensation.
The petitioner shall submit a copy of
the agreed-upon procedure and describe
the applicant’s failure to participate in
the procedure.
(ii) The applicant has failed to comply with the terms of an agreement on
compensation. The petitioner shall
submit a copy of the agreement, and
shall describe how the applicant has
failed to comply with the agreement.
(iii) The applicant has failed to participate in an arbitration proceeding.
The petitioner shall submit evidence of
such failure.
(iv) The applicant has failed to comply with the terms of an arbitration decision. The petitioner shall submit a
copy of the arbitration decision, and
describe how the applicant has failed to
comply with the decision.
(2) When no offer to pay has been
made, the petitioner shall state in his
petition the basis for the challenge,
and describe how the failure of the applicant to comply with the procedures
of this subpart has deprived him of the
rights accorded him under FIFRA section 3(c)(1)(F). Possible grounds for
challenge include, but are not limited
to, the following:
(i) The applicant has failed to list a
data requirement applicable to his
product, or has failed to demonstrate
compliance with all applicable data requirements.
(ii) The applicant has submitted or
cited a study that is not valid.
(iii) The applicant has submitted or
cited a study that does not satisfy the
data requirement for which it was submitted or cited.
(iv) The applicant has failed to comply with the procedure for showing
that a data gap exists.
(iv) The date the study was submitted to the Agency;
(v) The EPA document number assigned to the item of data (the Master
Record Identification Number or Accession Number), if known. If not
known, the EPA administrative number (such as the EPA Registration
Number, petition number, file symbol,
or permit number) with which the item
of data was submitted, such that the
Agency can identify the item of data.
(vi) A statement that the transferor
transfers irrevocably to the transferee
all rights, titles, and interest in the
items of data named;
(vii) A statement that the transferor
and transferee understand that any
false statement may be punishable
under 18 U.S.C. 1001; and
(viii) The names, signatures and titles of the transferor and transferee,
and the date signed.
(b) In addition, the original data submitter must submit to the Agency a
notarized statement affirming that:
(1) The person signing the transfer
agreement is authorized by the original
data submitter to bind the data submitter;
(2) No court order prohibits the
transfer, and any required court approvals have been obtained; and
(3) The transfer is authorized under
Federal, State, and local law and relevant corporate charters, bylaws or
partnership agreements.
(c) The Agency will acknowledge the
transfer of the data by notifying both
transferor and transferee, and will
state the effective date of the transfer.
Thereafter the transferee will be considered to be the original data submitter of the items of data transferred
for all purposes under FIFRA section
3(c)(1)(F), unless a new transfer agreement is submitted to the Agency.
[49 FR 30903, Aug. 1, 1984, as amended at 73
FR 75595, Dec. 12, 2008]
wreier-aviles on DSK7SPTVN1PROD with CFR
§ 152.99 Petitions to cancel registration.
An original data submitter may petition the Agency to deny or cancel the
registration of a product in accordance
with this section if he has submitted to
the Agency a valid study which, he
claims, satisfies a data requirement
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§ 152.100
40 CFR Ch. I (7–1–11 Edition)
(v) The applicant has improperly certified that a data gap exists. An original data submitter who has failed without good cause to respond to an applicant’s request for confirmation of a
data gap may not petition the Agency
for review on this basis.
(vi) The applicant has submitted or
cited a study originally submitted by
the petitioner, without the required
authorization or offer to pay.
(b) Procedure for petition to the Agency—(1) Time for filing. A petition under
paragraph (a)(1) of this section may be
filed at any time that the circumstances warrant. A petition under
paragraph (a)(2) of this section must be
filed within one year after the Agency
makes public the issuance of the registration.
(2) Notice to affected registrant. At the
same time that the petitioner files his
petition with the Agency, he shall send
a copy by certified mail to the affected
applicant or registrant. The applicant
or registrant shall have 60 days from
the date of his receipt of the petition
to submit written comments to the
Agency.
(c) Disposition of petitions. The Agency
will consider the material submitted
by the petitioner and the response, if
any, by the affected applicant or registrant.
(1) If the Agency determines that the
petition is without merit, it will inform the petitioner and the affected
applicant or registrant that the petition is denied. Denial of a petition is a
final Agency action.
(2) If the Agency determines that an
applicant has acted in any way described by paragraph (a)(1) of this section, the Agency will notify the petitioner and the affected applicant or
registrant that it intends to deny or
cancel the registration of the product
in support of which the data were
cited. The affected applicant or registrant will have 15 days from the date
of delivery of this notice to respond. If
the Agency determines, after considering any response, that the affected
applicant or registrant has acted in the
ways described by paragraph (a)(1) of
this section, the Agency will deny or
cancel the registration without further
hearing. Refer to FIFRA section
3(c)(1)(F)(ii). Denial or cancellation of
a registration is a final Agency action.
(3) Except as provided in paragraph
(c)(2) of this section, if the Agency determines that an applicant for registration of a product has acted in any way
that deprives an original data submitter of rights under FIFRA section
3(c)(1)(F), the Agency will take steps to
deny the application or cancel the registration, as appropriate. The procedures in FIFRA section 3(c)(6) or section 6(b) shall be followed. Denial or
cancellation is a final Agency action.
(d) Hearing. Any hearing will be conducted in accordance with the procedures in 40 CFR part 164. The only matter for resolution at the hearing shall
be whether the registrant failed to
comply with the requirements and procedures of FIFRA section 3(c)(1)(F) or
of this subpart, in the manner described by the petitioner. A decision
following a hearing shall be final.
[49 FR 30903, Aug. 1, 1984, as amended at 73
FR 75595, Dec. 12, 2008]
Subpart F—Agency Review of
Applications
SOURCE: 53 FR 15980, May 4, 1988, unless
otherwise noted.
§ 152.100 Scope.
(a) The Agency will follow the procedures in this subpart for all applications for registration, except an application for registration of a pesticide
that has been the subject of a previous
Agency cancellation or suspension notice under FIFRA sec. 6.
(b) The Agency will follow the procedures of subpart D of part 164 of this
chapter in evaluating any application
for registration of a pesticide involving
use of the pesticide in a manner that is
prohibited by a suspension or cancellation order, to the extent required by
subpart D of part 164.
§ 152.102 Publication.
The Agency will issue in the FEDERAL
REGISTER a notice of receipt of each application for registration of a product
that contains a new active ingredient
or that proposes a new use. After registration of the product, the Agency
will issue in the FEDERAL REGISTER a
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Environmental Protection Agency
§ 152.111
that have not previously been submitted to the Agency.
(b) The Agency normally will review
other data submitted or cited by an applicant only:
(1) As part of the process of reregistering currently registered products;
(2) When acting on an application for
registration of a product containing a
new active ingredient;
(3) If such data have been flagged in
accordance with § 158.34 or 161.34 of this
chapter; or
(4) When the Agency determines that
it would otherwise serve the public interest.
(c) If the Agency finds that it needs
additional data in order to determine
whether the product may be registered,
it will notify the applicant as early as
possible in the review process.
notice of issuance. The notice of
issuance will describe the new chemical or new use, summarize the Agency’s regulatory conclusions, list missing data and the conditions for their
submission, and respond to comments
received on the notice of application.
§ 152.104
Completeness of applications.
The applicant is responsible for the
accuracy and completeness of all information submitted in connection with
the application. The Agency will review each application to determine
whether it is complete. An application
is incomplete if any pertinent item
specified in § 152.50 has not been submitted, or has been incorrectly submitted (for example, data required by
part 158, or part 161 of this chapter, as
applicable, and not submitted in accordance with the requirements for format, claims of confidential business information, or flagging).
[53 FR 15980, May 4, 1988, as amended at 72
FR 61028, Oct. 26, 2007]
§ 152.108 Review of labeling.
The Agency will review all draft labeling submitted with the application.
If an applicant for amended registration submits only that portion of the
labeling proposed for amendment, the
Agency may review the entire label, as
revised by the proposed changes, in deciding whether to approve the amendment. The Agency will not approve
final printed labeling, but will selectively review it for compliance.
[72 FR 61028, Oct. 26, 2007
§ 152.105
Incomplete applications.
wreier-aviles on DSK7SPTVN1PROD with CFR
The Agency will not begin or continue the review of an application that
is incomplete. If the Agency determines that an application is incomplete or that further information is
needed in order to complete the Agency’s review, the Agency will notify the
applicant of the deficiencies and allow
the applicant 75 days to make corrections or additions to complete the application. If the applicant believes that
the deficiencies cannot be corrected
within 75 days, he must notify the
Agency within those 75 days of the date
on which he expects to complete the
application. If, after 75 days, the applicant has not responded, or if the applicant subsequently fails to complete the
application within the time scheduled
for completion, the Agency will terminate any action on such application,
and will treat the application as if it
had been withdrawn by the applicant.
Any subsequent submission relating to
the same product must be submitted as
a new application.
§ 152.107
§ 152.110 Time for agency review.
The Agency will complete its review
of applications as expeditiously as possible. Applications subject to specific
timeframes under the fee schedule established by FIFRA section 33 will be
reviewed within the timeframes established for the application or action
type.
[73 FR 75595, Dec. 12, 2008]
§ 152.111 Choice of standards for review of applications.
The Agency has discretion to review
applications under either the unconditional registration criteria of FIFRA
sec. 3(c)(5) or the conditional registration criteria of FIFRA sec. 3(c)(7). The
type of review chosen depends primarily on the extent to which the relevant data base has been reviewed for
Review of data.
(a) The Agency normally will review
data submitted with an application
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§ 152.112
40 CFR Ch. I (7–1–11 Edition)
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completeness and scientific validity.
EPA conducts data reviews needed to
support unconditional registrations on
a chemical-by-chemical basis, according to an established priority list. Except for applications for registration of
a new active ingredient or in special
cases where it finds immediate review
to be warranted, the Agency will not
commence a complete review of the existing data base on a given chemical in
response to receipt of an application
for registration. Instead the Agency
will review the application using the
criteria for conditional registration in
FIFRA sec. 3(c)(7) (A) and (B).
part, and parts 156 and 157 of this chapter;
(g) If the proposed labeling bears directions for use on food, animal feed, or
food or feed crops, or if the intended
use of the pesticide results or may reasonably be expected to result, directly
or indirectly, in pesticide residues (including residues of any active or inert
ingredient of the product, or of any metabolite or degradation product thereof) in or on food or animal feed, all necessary tolerances, exemptions from the
requirement of a tolerance, and food
additive regulations have been issued
under FFDCA sec. 408, and
(h) If the product, in addition to
being a pesticide, is a drug within the
meaning of FFDCA sec. 201(q), the
Agency has been notified by the Food
and Drug Administration (FDA) that
the product complies with any requirements imposed by FDA.
§ 152.112 Approval
of
registration
under FIFRA sec. 3(c)(5).
EPA will approve an application
under the criteria of FIFRA sec. 3(c)(5)
only if:
(a) The Agency has determined that
the application is complete and is accompanied by all materials required by
the Act and this part, including, but
not limited to, evidence of compliance
with subpart E of this part;
(b) The Agency has reviewed all relevant data in the possession of the
Agency (see §§ 152.107 and 152.111);
(c) The Agency has determined that
no additional data are necessary to
make the determinations required by
FIFRA sec. 3(c)(5) with respect to the
pesticide product which is the subject
of the application;
(d) The Agency has determined that
the composition of the product is such
as to warrant the proposed efficacy
claims for it, if efficacy data are required to be submitted for the product
by part 158 or part 161 of this chapter,
as applicable.
(e) The Agency has determined that
the product will perform its intended
function without unreasonable adverse
effects on the environment, and that,
when used in accordance with widespread and commonly recognized practice, the product will not generally
cause unreasonable adverse effects on
the environment;
(f) The Agency has determined that
the product is not misbranded as that
term is defined in FIFRA sec. 2(q) and
part 156 of this chapter, and its labeling and packaging comply with the applicable requirements of the Act, this
[53 FR 15980, May 4, 1988, as amended at 72
FR 61028, Oct. 26, 2007; 73 FR 75595, Dec. 12,
2008]
§ 152.113 Approval
of
registration
under FIFRA sec. 3(c)(7)—Products
that do not contain a new active ingredient.
(a) Except as provided in paragraph
(b) of this section, the Agency may approve an application for registration or
amended registration of a pesticide
product, each of whose active ingredients is contained in one or more other
registered peticide products, only if the
Agency has determined that:
(1) It possesses all data necessary to
make the determinations required by
FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide product which is
the subject of the application (including, at a minimum, data needed to
characterize any incremental risk that
would result from approval of the application);
(2) Approval of the application would
not significantly increase the risk of
any unreasonable adverse effect on the
environment; and
(3) The criteria of § 152.112(a), (d), and
(f) through (h) have been satisfied.
(b) Notwithstanding the provisions of
paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide under FIFRA
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Environmental Protection Agency
§ 152.115
sec. 3(c)(7)(A) unless the Agency has determined that the applicant’s product
and its proposed use are identical or
substantially similar to a currently
registered pesticide and use, or that
the pesticide and its proposed use differ
only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.
(c) Notwithstanding the provisions of
paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide product for a
new use under FIFRA sec. 3(c)(7)(B) if:
(1) The pesticide is the subject of a
special review, based on a use of the
product that results in human dietary
exposure; and
(2) The proposed new use involves use
on a major food or feed crop, or involves use on a minor food or feed crop
for which there is available an effective
alternative registered pesticide which
does not meet the risk criteria associated with human dietary exposure. The
determination of available and effective alternatives shall be made with
the concurrence of the Secretary of Agriculture.
(e) The registration of the pesticide
product and its subsequent use during
the period of the conditional registration are in the public interest.
§ 152.115 Conditions of registration.
(a) Substantially similar products and
new uses. Each registration issued
under § 152.113 shall be conditioned
upon the submission or citation by the
registrant of all data which are required for unconditional registration of
his product under FIFRA sec. 3(c)(5),
but which have not yet been submitted,
no later than the time such data are
required to be submitted for similar
pesticide products already registered.
If a notice requiring submission of such
data has been issued under FIFRA sec.
3(c)(2)(B) prior to the date of approval
of the application, the applicant must
submit or cite the data described by
that notice at the time specified by
that notice. The applicant must agree
to these conditions before the application may be approved.
(b) New active ingredients. Each registration issued under § 152.114 shall be
conditioned upon the applicant’s agreement to each of the following conditions:
(1) The applicant will submit remaining required data (and interim reports
if required) in accordance with a schedule approved by the Agency.
(2) The registration will expire upon
a date established by the Agency, if the
registrant fails to submit data as required by the Agency. The expiration
date will be established based upon the
length of time necessary to generate
and submit the required data. If the
studies are submitted in a timely manner, the registration will be cancelled
if the Agency determines, based on the
data (alone, or in conjuction with other
data), that the product or one or more
of its uses meets or exceeds any of the
risk criteria established by the Agency
to initiate a special review. If the
Agency so determines, it will issue to
the registrant a Notice of Intent to
Cancel under FIFRA sec. 6(e), and will
specify any provisions for sale and distribution of existing stocks of the pesticide product.
(3) The applicant will submit an annual report of the production of the
product.
wreier-aviles on DSK7SPTVN1PROD with CFR
§ 152.114 Approval
of
registration
under FIFRA sec. 3(c)(7)—Products
that contain a new active ingredient.
An application for registration of a
pesticide containing an active ingredient not in any currently registered
product may be conditionally approved
for a period of time sufficient for the
generation and submission of certain of
the data necessary for a finding of
registrability under FIFRA sec. 3(c)(5)
if the Agency determines that:
(a) Insufficient time has elapsed
since the imposition of the data requirement for those data to have been
developed;
(b) All other required test data and
materials have been submitted to the
Agency;
(c) The criteria in § 152.112(a), (b), (d),
and (f) through (h) have been satisfied;
(d) The use of the pesticide product
during the period of the conditional
registration will not cause any unreasonable adverse effect on the environment; and
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§ 152.116
40 CFR Ch. I (7–1–11 Edition)
(c) Other conditions. The Agency may
establish, on a case-by-case basis, other
conditions applicable to registrations
to be issued under FIFRA sec. 3(c)(7).
(d) Cancellation if condition is not satisfied. If any condition of the registration of the product is not satisfied, or
if the Agency determines that the registrant has failed to initiate or pursue
appropriate action towards fulfillment
of any condition, the Agency will issue
a notice of intent to cancel under
FIFRA sec. 6(e).
section to that exclusive use data submitter.
[53 FR 15980, May 4, 1988, as amended at 60
FR 32096, June 19, 1995]
(a) Basis for denial. The Agency may
deny an application for registration if
the Agency determines that the pesticide product does not meet the criteria for registration under either
FIFRA sec. 3(c)(5) or (7), as specified in
§§ 152.112 through 152.114.
(b) Notification of applicant. If the
Agency determines that an application
should be denied, it will notify the applicant by certified letter. The letter
will set forth the reasons and factual
basis for the determination with conditions, if any, which must be fulfilled in
order for the registration to be approved.
(c) Opportunity for remedy by the applicant. The applicant will have 30 days
from the date of receipt of the certified
letter to take the specified corrective
action. During this time the applicant
may request that his application be
withdrawn.
(d) Notice of denial. If the applicant
fails to correct the deficiencies within
the 30-day period, the Agency may
issue a notice of denial, which will be
published in the FEDERAL REGISTER,
and which will set forth the reasons
and the factual basis for the denial.
(e) Hearing rights. Within 30 days following the publication of the notice of
denial, an applicant, or any interested
person with written authorization of
the applicant, may request a hearing in
accordance with FIFRA sec. 6(b). Hearings will be conducted in accordance
with part 164 of this chapter.
[53 FR 15980, May 4, 1988, as amended at 73
FR 75595, Dec. 12, 2008]
§ 152.117
Notification to applicant.
The Agency will notify the applicant
of the approval of his application by a
Notice of Registration for new registration, or by a letter in the case of an
amended registration.
§ 152.118
§ 152.116 Notice of intent to register to
original submitters of exclusive use
data.
(a) Except as provided in paragraph
(c) of this section, at least 30 days before registration of a product containing an active ingredient for which
a previously submitted study is eligible
for exclusive use under FIFRA sec.
3(c)(1)(F)(i), the Agency will notify the
original submitter of the exclusive use
study of the intended registration of
the product. If requested by the exclusive use data submitter within 30 days,
the Agency will also provide the applicant’s list of data requirements and
method of demonstrating compliance
with each data requirement.
(b) Within 30 days after receipt of the
Agency’s notice, or of the applicant’s
list of data requirements, whichever is
later, the exclusive use data submitter
may challenge the issuance of the registration in accordance with the procedures in § 152.99 (b) and (c). If the Agency finds that the challenge has merit,
it will issue a notice of denial of the
application. The applicant may then
avail himself of the hearing procedures
provided by FIFRA sec. 3(c)(6). If the
Agency finds that the challenge is
without merit, it will deny the petition
and register the applicant’s product.
Denial of the petition is a final Agency
action.
(c) If an applicant has submitted to
the Agency a certification from an exclusive use data submitter that he is
aware of the applicant’s application for
registration, and does not object to the
issuance of the registration, the Agency will not provide the 30-day notification described in paragraph (a) of this
Denial of application.
§ 152.119 Availability of material
support of registration.
(a) The information submitted to
support a registration application shall
be part of the official Agency file for
that registration.
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Environmental Protection Agency
§ 152.130
shall, in accordance with FIFRA section 6(a)(2) and the requirements of
part 159, subpart D of this chapter, provide such information to the Agency,
clearly identified as FIFRA 6(a)(2)
data.
(b) Within 30 days after registration,
the Agency will make available for
public inspection, upon request, the
materials required by subpart E to be
submitted with an application. Materials that will be publicly available include an applicant’s list of data requirements, the method used by the applicant to demonstrate compliance for
each data requirement, and the applicant’s citations of specific studies in
the Agency’s possession if applicable.
(c) Except as provided by FIFRA sec.
10, within 30 days after registration,
the data on which the Agency based its
decision to register the product will be
made available for public inspection,
upon request, in accordance with the
procedures in 40 CFR part 2.
[73 FR 75595, Dec. 12, 2008]
§ 152.130 Distribution under approved
labeling.
(a) A registrant may distribute or
sell a registered product with the composition, packaging and labeling currently approved by the Agency.
(b) A registrant may distribute or
sell a product under labeling bearing
any subset of the approved directions
for use, provided that in limiting the
uses listed on the label, no changes
would be necessary in precautionary
statements, use classification, or packaging of the product.
(c) Normally, if the product labeling
is amended on the initiative of the registrant, by submission of an application for amended registration, the registrant may distribute or sell under the
previously approved labeling for a period of 18 months after approval of the
revision, unless an order subsequently
issued by the Agency under FIFRA sec.
6 or 13 provides otherwise. However, if
paragraph (d) of this section applies to
the registrant’s product, the time
frames established by the Agency in
accordance with that paragraph shall
take precedence.
(d) If a product’s labeling is required
to be revised as a result of the issuance
of a Registration Standard, a Label Improvement Program notice, or a notice
concluding a special review process,
the Agency will specify in the notice to
the registrant the period of time that
previously approved labeling may be
used. In all cases, supplemental or
sticker labeling may be used as an interim compliance measure for a reasonable period of time. The Agency
may establish dates as follows governing when label changes must appear
on labels:
(1) The Agency may establish a date
after which all product distributed or
sold by the registrant must bear revised labeling.
(2) The Agency may also establish a
date after which no product may be
Subpart G—Obligations and
Rights of Registrants
SOURCE: 53 FR 15983, May 4, 1988, unless
otherwise noted.
wreier-aviles on DSK7SPTVN1PROD with CFR
§ 152.122 Currency
of
address
of
record and authorized agent.
(a) The registrant must keep the
Agency informed of his current name
and address of record. If the Agency’s
good faith attempts to contact the registrant are not successful, the Agency
will issue in the FEDERAL REGISTER a
notice of intent to cancel all products
of the registrant under FIFRA sec. 6(b).
The registrant must respond within 30
days requesting that the registrations
be maintained in effect, and providing
his name and address of record. If no
response is received, the cancellations
will become effective at the end of 30
days without further notice to the registrant. The Agency may make provision for the sale and distribution of existing stocks of such products after the
effective date of cancellation.
(b) The registrant must also notify
the Agency if he changes his authorized agent.
§ 152.125 Submission of information
pertaining to adverse effects.
If at any time the registrant receives
or becomes aware of any factual information regarding unreasonable adverse
effects of the pesticide on the environment that has not previously been submitted to the Agency, the registrant
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§ 152.132
40 CFR Ch. I (7–1–11 Edition)
(4) The establishment number must
be that of the final establishment at
which the product was produced; and
(5) Specific claims may be deleted,
provided that no other changes are necessary.
(e) Voluntary cancellation of a product applies to the registered product
and all distributor products distributed
or sold under that registration number.
The registrant is responsible for ensuring that distributors under his cancelled registration are notified and
comply with the terms of the cancellation.
distributed or sold by any person unless it bears revised labeling. This date
will provide sufficient time for product
in channels of trade to be distributed
or sold to users or otherwise disposed
of.
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§ 152.132
Supplemental distribution.
The registrant may distribute or sell
his registered product under another
person’s name and address instead of
(or in addition to) his own. Such distribution and sale is termed ‘‘supplemental distribution’’ and the product
is referred to as a ‘‘distributor product.’’ The distributor is considered an
agent of the registrant for all intents
and purposes under the Act, and both
the registrant and the distributor may
be held liable for violations pertaining
to the distributor product. Supplemental distribution is permitted upon
notification to the Agency if all the
following conditions are met:
(a) The registrant has submitted to
the Agency for each distributor product a statement signed by both the registrant and the distributor listing the
names and addresses of the registrant
and the distributor, the distributor’s
company number, the additional brand
name(s) to be used, and the registration number of the registered product.
(b) The distributor product is produced, packaged and labeled in a registered establishment operated by the
same producer (or under contract in accordance with § 152.30) who produces,
packages, and labels the registered
product.
(c) The distributor product is not repackaged (remains in the producer’s
unopened container).
(d) The label of the distributor product is the same as that of the registered product, except that:
(1) The product name of the distributor product may be different (but
may not be misleading);
(2) The name and address of the distributor may appear instead of that of
the registrant;
(3) The registration number of the
registered product must be followed by
a dash, followed by the distributor’s
company number (obtainable from the
Agency upon request);
[53 FR 15975, May 4, 1988, as amended at 60
FR 32096, June 19, 1995]
§ 152.135
Transfer of registration.
(a) A registrant may transfer the registration of a product to another person, and the registered product may be
distributed and sold without the requirement of a new application for registration by that other person, if the
parties submit to the Agency the documents listed in paragraphs (b) and (c)
of this section, and receive Agency approval as described in paragraph (d) of
this section.
(b) Persons seeking approval of a
transfer of registration must provide a
document signed by the authorized representative of the registrant (the
transferor) and of the person to whom
the registration is transferred (the
transferee) that contains the following
information:
(1) The name, address and State of incorporation (if any) of the transferor;
(2) The name, address and State of incorporation of the transferee;
(3) The name(s) and EPA registration
number(s) of the product(s) being
transferred;
(4) A statement that the transferor
transfers irrevocably to the transferee
all right, title, and interest in the EPA
registration(s) listed in the document;
(5) A statement that the transferred
registration(s) shall not serve as collateral or otherwise secure any loan or
other payment arrangement or executory promise, and that the registration(s) shall not revert to the transferor unless a new transfer agreement
is submitted to and approved by the
Agency;
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Environmental Protection Agency
§ 152.164
quired by this section for both the registration and the data.
(6) A description of the general nature of the underlying transaction,
e.g., merger, spinoff, bankruptcy transfer (no financial information need be
disclosed);
(7) A statement that the transferor
and transferee understand that any
false statement may be punishable
under 18 U.S.C. 1001; and
(8) An acknowledgment by the transferee that his rights and duties concerning the registration under FIFRA
and this chapter will be deemed by
EPA to be the same as those of the
transferor at the time the transfer is
approved.
(c) In addition, the transferor must
submit to the Agency a notarized
statement affirming that:
(1) The person signing the transfer
agreement is authorized by the registrant to bind the transferor;
(2) No court order prohibits the
transfer, and that any required court
approvals have been obtained; and
(3) The transfer is authorized under
all relevant Federal, State and local
laws and all relevant corporate charters, bylaws, partnerships, or other
agreements.
(d) If the required documents are submitted, and no information available
to the Agency indicates that the information is incorrect, the Agency will
approve the transfer without requiring
that the transferee obtain a new registration. The Agency will notify the
transferor and transferee of its approval.
(e) The transfer will be effective on
the date of Agency approval. Thereafter the transferee will be regarded as
the registrant for all purposes under
FIFRA.
(f) Rights to exclusive use of data or
compensation under FIFRA section
3(c)(1)(F) are separate from the registration itself and may be retained by
the transferor, or may be transferred
independently in accordance with the
provisions of § 152.98. If the registrant
as the original data submitter wishes
to transfer data rights at the same
time as he transfers the registration,
he may submit a single transfer document containing the information re-
[53 FR 15983, May 4, 1988, as amended at 58
FR 34203, June 23, 1993; 73 FR 75595, Dec. 12,
2008]
Subpart H [Reserved]
Subpart I—Classification of
Pesticides
SOURCE: 53 FR 15986, May 4, 1988, unless
otherwise noted.
§ 152.160 Scope.
(a) Types of classification. A pesticide
product may be unclassified, or it may
be classified for restricted use or for
general use. The Agency does not normally classify products for general use;
products that are not restricted remain
unclassified.
(b) Kinds of restrictions. The Agency
may restrict a product or its uses to
use by a certified applicator, or by or
under the direct supervision of a certified applicator, as described in
FIFRA sec. 3(d)(1)(C). The Agency may
also, by regulation, prescribe restrictions relating to the product’s composition, labeling, packaging, uses, or
distribution and sale, or to the status
or qualifications of the user.
§ 152.161 Definitions.
In addition to the definitions in
§ 152.3, the following terms are defined
for the purposes of this subpart:
(a) Dietary LC50 means a statistically
derived estimate of the concentration
of a test substance in the diet that
would cause 50 percent mortality to
the test population under specified conditions.
(b) Outdoor use means any pesticide
application that occurs outside enclosed manmade structures or the consequences of which extend beyond enclosed manmade structures, including,
but not limited to, pulp and paper mill
water treatments and industrial cooling water treatments.
§ 152.164 Classification procedures.
(a) Grouping of products for classification purposes. In its discretion, the
Agency may identify a group of products having common characteristics or
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§ 152.166
40 CFR Ch. I (7–1–11 Edition)
uses and may classify for restricted use
same or all of the products or uses included in that group. Such a group may
be comprised of, but is not limited to,
products that:
(1) Contain the same active ingredients.
(2) Contain the same active ingredients in a particular concentration
range, formulation type, or combination of concentration range and formulation type.
(3) Have uses in common.
(4) Have other characteristics, such
as toxicity, flammability, or physical
properties, in common.
(b) Classification reviews. The Agency
may conduct classification reviews and
classify products at any time, if it determines that a restriction on the use
of a pesticide product is necessary to
avoid unreasonable adverse effects on
the environment. However, classification reviews normally will be conducted and products classified only in
the following circumstances:
(1) As part of the review of an application for new registration of a product
containing an active ingredient not
contained in any currently registered
product.
(2) As part of the review of an application for a new use of a product, if existing uses of that product previously
have been classified for restricted use.
Review of a restricted use product at
this time is for the purpose of determining whether the new use should
also be classified for restricted use.
Normally the Agency will not conduct
initial classification reviews for existing uses of individual products in conjunction with an application for
amended registration.
(3) As part of the process of developing or amending a registration
standard for a pesticide. The Agency
normally will conduct classification reviews of all uses of a currently registered pesticide at this time.
(4) As part of any special review of a
pesticide, in accordance with the procedures of 40 CFR part 154.
(c) Classification procedures. (1) If the
Agency determines that a product or
one or more of its uses should be classified for restricted use, the Agency initially may classify the product by regulation. In this case, within 60 days
after the effective date of a final rule,
each registrant of a product subject to
the rule must submit to the Agency
one of the following, as directed in the
final rule:
(i) A copy of the amended label and
any supplemental labeling to be used
as an interim compliance measure.
(ii) A statement, which the Agency
considers a report under the Act, that
the registrant will comply with the labeling requirements prescribed by the
Agency within the timeframes prescribed by the regulation.
(iii) An application for amended registration to delete the uses which have
been restricted, or to ‘‘split’’ the registration into two registrations, one including only restricted or all uses, and
the other including only uses that have
not been classified.
(2) Alternatively, EPA may notify
the applicant or registrant of the classification decision and require that he
submit the information required by
paragraph (c)(1) of this section. The
Agency may deny registration or initiate cancellation proceedings if the
registrant fails to comply within the
timeframes established by the Agency
in its notification.
§ 152.166 Labeling
products.
of
restricted
(a) Products intended for end use. A
product whose labeling bears directions
for end use and that has been classified
for restricted use must be labeled in accordance with the requirements of
§ 156.10 of this chapter or other Agency
instructions. The Agency will permit
the use of stickers or supplemental labeling as an interim alternative to the
use of an approved amended label, in
accordance with § 152.167.
(b) Products intended only for formulation. A product whose labeling does not
bear directions for end use (a product
that is intended and labeled solely for
further formulation into other pesticide products) is not subject to the
labeling requirements of this subpart.
§ 152.167 Distribution and sale of restricted use products.
Unless modified by the Agency, the
compliance dates in this section shall
apply to restricted use products.
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Environmental Protection Agency
§ 152.170
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(a) Sale by registrant or producer. (1)
No product with a use classified for restricted use may be distributed or sold
by the registrant or producer after the
120th day after the effective date of
such classification unless the product:
(i) Bears an approved amended label
which contains the terms of restricted
use imposed by the Agency and otherwise complies with part 156 of this
chapter;
(ii) Bears a sticker containing the
product name, EPA registration number, and any terms of restricted use imposed by the Agency; or
(iii) Is accompanied by supplemental
labeling bearing the information listed
in paragraph (a)(1)(ii) of this section.
(2) If the registrant chooses to delete
the restricted uses from his product
label, that product may not be distributed or sold after the 180th day after
the effective date of classification unless the product bears amended labeling with the restricted uses deleted.
(3) Notwithstanding paragraphs (a)
(1) and (2) of this section, after the
270th day after the effective date of
classification, no registrant or producer may distribute or sell a product
that does not bear the approved amended label. After that date, stickers and
supplemental labeling described in
paragraph (a)(1) (ii) and (iii) are no
longer acceptable.
(b) Sale by retailer. No product with a
use classified for restricted use by a
regulation may be distributed or sold
by a retailer or other person after the
270th day after the effective date of the
final rule unless the product bears a
label or labeling which complies with
paragraph (a)(1) of this section.
(2) Newspapers, magazines, newsletters and other material in circulation or available to the public.
(3) Broadcast media such as radio and
television.
(4) Telephone advertising.
(5) Billboards and posters.
(c) The requirement may be satisfied
for printed material by inclusion of the
statement ‘‘Restricted Use Pesticide,’’
or the terms of restriction, prominently in the advertisement. The requirement may be satisfied with respect to broadcast or telephone advertising by inclusion in the broadcast of
the spoken words ‘‘Restricted use pesticide,’’ or a statement of the terms of
restriction.
(d) The requirements of this section
shall be effective:
(1) After 270 days after the effective
date of restriction of a product that is
currently registered, unless the Agency
specifies a shorter time period;
(2) Upon the effective date of registration of a product not currently
registered.
§ 152.170 Criteria for restriction to use
by certified applicators.
(a) General criteria. An end-use product will be restricted to use by certified applicators (or persons under
their direct supervision) if the Agency
determines that:
(1) Its toxicity exceeds one or more of
the specific hazard criteria in paragraph (b) or (c) of this section, or evidence described in paragraph (d) of this
section substantiates that the product
or use poses a serious hazard that may
be mitigated by restricting its use;
(2) Its labeling, when considered according to the factors in paragraph
(e)(2) of this section, is not adequate to
mitigate these hazard(s);
(3) Restriction of the product would
decrease the risk of adverse effects;
and
(4) The decrease in risks of the pesticide as a result of restriction would
exceed the decrease in benefits.
(b) Criteria for human hazard—(1) Residential and institutional uses. A pesticide product intended for residential
or institutional use will be considered
for restricted use classification if:
§ 152.168 Advertising of restricted use
products.
(a) Any product classified for restricted use shall not be advertised unless the advertisement contains a
statement of its restricted use classification.
(b) The requirement in paragraph (a)
of this section applies to all advertisements of the product, including, but
not limited, to:
(1) Brochures, pamphlets, circulars
and similar material offered to purchasers at the point of sale or by direct
mail.
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§ 152.170
40 CFR Ch. I (7–1–11 Edition)
(i) The pesticide, as diluted for use,
has an acute oral LD50 of 1.5 g/kg or
less;
(ii) The pesticide, as formulated, has
an acute dermal LD50 of 2000 mg/kg or
less;
(iii) The pesticide, as formulated, has
an acute inhalation LC50 of 0.5 mg/liter
or less, based upon a 4-hour exposure
period;
(iv) The pesticide, as formulated, is
corrosive to the eye (causes irreversible destruction of ocular tissue) or results in corneal involvement or irritation persisting for more than 7 days;
(v) The pesticide, as formulated, is
corrosive to the skin (causes tissue destruction into the dermis and/or scarring) or causes severe irritation (severe
erythema or edema) at 72 hours; or
(vi) When used in accordance with
label directions, or widespread and
commonly recognized practice, the pesticide may cause significant subchronic, chronic or delayed toxic effects on man as a result of single or
multiple exposures to the product ingredients or residues.
(2) All other uses. A pesticide product
intended for uses other than residential
or institutional use will be considered
for restricted use classification if:
(i) The pesticide, as formulated, has
an acute oral LD50 of 50 mg/kg or less;
(ii) The pesticide, as formulated, has
an acute dermal LD50 of 200 mg/kg or
less;
(iii) The pesticide, as diluted for use,
has an acute dermal LD50 of 16 g/kg or
less;
(iv) The pesticide, as formulated, has
an acute inhalation LC50 of 0.05 mg/
liter or less, based upon a 4-hour exposure period;
(v) The pesticide, as formulated, is
corrosive to the eye or causes corneal
involvement or irritation persisting for
more than 21 days;
(vi) The pesticide, as formulated, is
corrosive to the skin (causes tissue destruction into the dermis and/or scarring); or
(vii) When used in accordance with
label directions, or widespread and
commonly recognized practice, the pesticide may cause significant subchronic toxicity, chronic toxicity, or
delayed toxic effects on man, as a re-
sult of single or multiple exposures to
the product ingredients or residues.
(c) Criteria for hazard to non-target
species—(1) All products. A pesticide
product intended for outdoor use will
be considered for restricted use classification if:
(i) When used according to label directions, application results in residues
of the pesticide, its metabolites, or its
degradation products, in the diet of exposed mammalian wildlife, immediately after application, such that:
(A) The level of such residues equals
or exceeds one-fifth of the acute dietary LC50; or
(B) The amount of pesticide consumed in one feeding day (mg/kg/day)
equals or exceeds one-fifth of the mammalian acute oral LD50;
(ii) When used according to label directions, application results, immediately after application, in residues of
the pesticide, its metabolites or its
degradation products, in the diet of exposed birds at levels that equal or exceed one-fifth of the avian subacute dietary LC50;
(iii) When used according to label directions, application results in residues
of the pesticide, its metabolites or its
degradation products, in water that
equal or exceed one-tenth of the acute
LC50 for non-target aquatic organisms
likely to be exposed; or
(iv) Under conditions of label use or
widespread and commonly recognized
practice, the pesticide may cause discernible adverse effects on non-target
organisms, such as significant mortality or effects on the physiology,
growth, population levels or reproduction rates of such organisms, resulting
from direct or indirect exposure to the
pesticide, its metabolites or its degradation products.
(2) Granular products. In addition to
the criteria of paragraph (c)(1) of this
section, a pesticide intended for outdoor use and formulated as a granular
product will be considered for restricted use classification if:
(i) The formulated product has an
acute avian or mammalian oral LD50 of
50 mg/kg or less as determined by extrapolation from tests conducted with
technical material or directly with the
formulated product; and
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Environmental Protection Agency
§ 152.175
(ii) It is intended to be applied in
such a manner that significant exposure to birds or mammals may occur.
(d) Other evidence. The Agency may
also consider evidence such as field
studies, use history, accident data,
monitoring data, or other pertinent
evidence in deciding whether the product or use may pose a serious hazard to
man or the environment that can reasonably be mitigated by restricted use
classification.
(e) Alternative labeling language. (1) If
the Agency determines that a product
meets one or more of the criteria of
paragraphs (b) or (c) of this section, or
if other evidence identified in paragraph (d) of this section leads the
Agency to conclude that the product
should be considered for restricted use
classification, the Agency will then determine if additional labeling language
would be adequate to mitigate the
identified hazard(s) without restricted
use classification. If the labeling language meets all the criteria specified
in paragraph (e)(2) of this section, the
product will not be classified for restricted use.
(2) The labeling will be judged adequate if it meets all the following criteria:
(i) The user, in order to follow label
directions, would not be required to
perform complex operations or procedures requiring specialized training
and/or experience.
§ 152.175
(ii) The label directions do not call
for specialized apparatus, protective
equipment, or materials that reasonably would not be available to the general public.
(iii) Failure to follow label directions
in a minor way would result in few or
no significant adverse effects.
(iv) Following directions for use
would result in few or no significant
adverse effects of a delayed or indirect
nature through bioaccumulation, persistence, or pesticide movement from
the original application site.
(v) Widespread and commonly recognized practices of use would not nullify
or detract from label directions such
that unreasonable adverse effects on
the environment might occur.
§ 152.171 Restrictions other than those
relating to use by certified applicators.
The Agency may by regulation impose restrictions on a product or class
of products if it determines that:
(a) Without such restrictions, the
product when used in accordance with
warnings, cautions and directions for
use or in accordance with widespread
and commonly recognized practices of
use may cause unreasonable adverse effects on the environment; and
(b) The decrease in risks as a result
of restricted use would exceed the decrease in benefits as a result of restricted use.
Pesticides classified for restricted use.
The following uses of pesticide products containing the active ingredients specified below have been classified for restricted use and are limited to use by or
under the direct supervision of a certified applicator.
Active ingredient
Formulation
Use pattern
Classification 1
Criteria influencing restriction
Acrolein .............
As sole active ingredient. No mixtures registered.
All uses ...................
Restricted .........
Aldicarb .............
As sole active ingredient ..................
Ornamental uses
(indoor and outdoor).
Agricultural crop
uses.
......do ......................
......do ...............
Inhalation hazard to humans. Residue effects on
avian species and aquatic
organisms.
Other hazards—accident
history.
Under further
evaluation.
......do ...............
......do ......................
......do ...............
......do ......................
Under futher
evaluation..
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No mixtures registered .....................
Aluminum
phosphide.
Azinphos methyl
As sole active ingredient. No mixtures registered.
All liquids with a concentration greater than 13.5 pct.
All other formulations ........................
Inhalation hazard to humans.
Do.
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§ 152.175
40 CFR Ch. I (7–1–11 Edition)
Formulation
Use pattern
Classification 1
Carbofuran ........
All concentrate suspensions and
wettable powders 40% and greater.
All granular formulations ...................
......do ......................
......do ...............
Rice ........................
All uses except rice
Under evaluation.
......do.
All uses ...................
Rodent control ........
......do ...............
......do ...............
Outdoor uses (other
than rodent control).
All uses ...................
Unclassified.
Restricted .........
Acute inhalation toxicity.
Molluscide uses ......
Restricted .........
Effects on aquatic organisms.
Pressurized sprays 0.55% and less
All liquid formulations 8% and greater.
Hospital antiseptics
All uses ...................
Unclassified.
Restricted .........
All emulsifiable concentrates 65%
and greater, all emulsifiable concentrates and concentrate solutions 21% and greater with
fensulfothion 43% and greater, all
emulsifiable concentrates 32%
and greater in combination with
32% fensulfothion and greater.
Non-aqueous solution 95% and
greater.
Granular formulations 10% and
greater.
Emulsifiable concentrates 40% and
greater.
All granular and fertilizer formulations.
All granular and dust formulations
greater than 2 pct, fertilizer formulations, wettable powders, emulsifiable concentrates, concentrated
suspensions, concentrated solutions.
Smoke fumigants ..............................
......do ......................
Restricted .........
Commercial seed
treatment.
Indoor uses (greenhouse).
Aquatic uses ...........
Restricted .........
Acute dermal toxicity.
......do ...............
Acute inhalation toxicity.
......do ...............
Acute dermal toxicity.
Chloropicrin ......
All granular and fertilizer formulations.
All formulations greater than 2% ......
All formulations .................................
All formulations 2% and less ............
Clonitralid ..........
Dicrotophos ......
Disulfoton ..........
Ethoprop ...........
Ethyl parathion
Fenamiphos ......
Fonofos .............
Methamidophos
Methidathion .....
All wettable powders 70% and greater.
All granulars and wettable powders
Methomyl ..........
All uses ...................
......do ......................
Under evaluation.
Restricted .........
......do ......................
......do ...............
Acute inhalation toxicity.
Acute inhalation toxicity.
Hazard to non-target organisms.
Acute dermal toxicity; residue effects on avian species (except for tree injections).
Do.
Acute inhalation toxicity.
Inhalation hazard to humans. Acute dermal toxicity. Residue effects on
mammalian, aquatic,
avian species.
......do ......................
......do ...............
......do ......................
......do ...............
Inhalation hazard to humans.
Other hazards—accident
history.
Acute dermal toxicity.
......do ......................
......do ...............
Acute dermal toxicity.
Tobacco ..................
Unclassified.
......do ......................
Restricted .........
Dust formulations 2.5% and greater
......do ......................
......do ...............
All formulations .................................
All uses except
nursery stock,
safflower and
sunflower.
Nursery stock, safflower and sunflower.
Nondomestic outdoors-agricultural
crops, ornamental
and turf. All other
registered uses.
......do ...............
Dust and granular formulations 2 pct
and below.
Emulsifiable concentrates 35% and
greater.
Emulsifiable concentrates 44% and
greater.
Emulsifiable concentrates 12.6%
and less with pebulate 50.3% and
less.
Liquid formulations 40% and greater
All formulations .................................
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Criteria influencing restriction
Active ingredient
As sole active ingredient in 1 pct to
2.5 baits (except 1 pct fly bait).
Acute dermal toxicity; residue effects on avian species.
Residue effects on avian
species.
Do.
Unclassified.
Restricted .........
Residue effects on mammalian species.
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Environmental Protection Agency
Formulation
Use pattern
Classification 1
Criteria influencing restriction
All concentrated solution formulations.
90 pct wettable powder formulations
(not in water soluble bags).
90 pct wettable powder formulation
in water soluble bags.
All granular formulations ...................
25 pct wettable powder formulations
In 1.24 pct to 2.5 pct dusts as sole
active ingredient and in mixtures
with fungicides and chlorinated hydrocarbon, inorganic phosphate
and biological insecticides.
All formulations in containers greater
than 1.5 lb.
Containers with not more than 1.5 lb
of methyl bromide with 0.25 pct to
2.0 pct chloropicrin as an indicator.
......do ......................
......do ...............
......do ......................
......do ...............
Other hazards-accident history.
Do.
Active ingredient
Methyl bromide
Methyl parathion
Nicotine (alkaloid).
Paraquat (dichloride) and
paraquat
bis(methyl sulfate).
Phorate .............
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Phosphamidon ..
§ 152.175
......do ......................
Unclassified.
......do ......................
......do ......................
......do ......................
......do.
......do.
......do.
All uses ...................
Restricted .........
Single applications
(nondomestic
use) for soil treatment in closed
systems.
All uses ...................
Unclassified.
Restricted .........
......do ......................
......do ...............
Microencapsulated ............................
......do ......................
......do ...............
All dust and granular formulations 5
pct and greater and all wettable
powders and liquids.
Liquid and dry formulations 14% and
above.
All formulations .................................
......do ......................
......do ...............
Indoor (greenhouse)
......do ...............
Applications to cranberries.
All uses (domestic
and nondomestic).
All uses ...................
......do ...............
Container with not more than 1.5 lb
having no indicator.
All dust and granular formulations
less than 5 pct.
Liquid and dry formulations 1.5%
and less.
All formulations and concentrations
except those listed below.
Pressurized spray formulations containing
0.44
pct
Paraquat
bis(methyl sulfate) and 15 pct petroleum distillates as active ingredients.
Liquid fertilizers containing concentrations of 0.025 pct paraquat
dichloride and 0.03 percent
atrazine; 0.03 pct paraquat dichloride and 0.37 pct atrazine, 0.04
pct paraquat dichloride and 0.49
pct atrazine.
Liquid formulations 65% and greater
Do.
Do.
Other hazards-accident history. All foliar applications
restricted based on residue effects on mammalian and avian species.
Residue effects on avian
species. Hazard to bees.
Acute dermal toxicity. Residue effects on mammalian and avian species.
Acute inhalation toxicity.
Effects on aquatic organisms.
Unclassified.
Restricted .........
Spot weed and
grass control.
......do.
All uses ...................
Unclassified.
......do ......................
Restricted .........
All granular formulations ...................
Rice ........................
......do ...............
Liquid formulations 75% and greater
......do ......................
......do ...............
Dust formulations 1.5% and greater
......do ......................
......do ...............
Other hazards. Use and accident history, human toxicological data.
Acute dermal toxicity.
Residue effects on avian
species (applies to foliar
applications only).
Residue effects on mammalian species (applies to
foliar application only).
Effects on aquatic organisms.
Acute dermal toxicity.
Residue effects on mammalian species.
Residue effects on avian
species.
Do.
Residue effects on mammalian species.
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§ 152.400
40 CFR Ch. I (7–1–11 Edition)
Active ingredient
Formulation
Use pattern
Classification 1
Criteria influencing restriction
Picloram ............
All formulations and concentrations
except tordon 101 R.
......do ......................
......do ...............
Hazard to nontarget organisms (specifically nontarget plants both crop and
noncrop).
Tordon 101 R forestry herbicide containing 5.4 pct picloram and 20.9
pct 2.4–D.
All capsules and ball formulations ....
Control of unwanted
trees by cut surface treatment.
All uses ...................
Unclassified.
Restricted .........
All solutions and dry baits ................
......do ......................
......do ...............
All dry baits, pellets and powder formulations greater than 0.5 pct.
......do ......................
......do ...............
All uses calling for
burrow builders.
All uses except subsoil.
All subsoil uses ......
All uses ...................
......do ...............
Sulfotepp ..........
All dry baits, pellets and powder formulations.
All dry baits, pellets and powder formulations 0.5 pct and below.
......do ................................................
Sprays and smoke generators .........
Zinc Phosphide
All formulations 2% and less ............
All domestic uses
and non-domestic
uses in and
around buildings.
Unclassified.
Non-domestic outdoor uses (other
than around buildings).
Domestic uses ........
......do ...............
Hazard to non-target organisms.
......do ...............
Acute oral toxicity.
Sodium cyanide 3.
Sodium
fluoroacetate.
Strychnine .........
......do ...............
Unclassified.
Restricted .........
Inhalation hazard to humans.
Acute oral toxicity. Hazard
to nontarget organisms.
Use and accident history.
Acute oral toxicity. Hazard
to nontarget avain species. Use and accident
history.
Hazard to nontarget organisms.
Do.
Inhalation hazard to humans.
All dry formulations 60% and greater..
All bait formulations ..........................
All dry formulations 10% and greater
1 ‘‘Under
evaluation’’ means no classification decision has been made and the use/formulation in question is still under active
review within EPA.
2 Percentages given are the total of dioxathion plus related compounds.
3 (NOTE—M–44 sodium cyanide capsules may only be used by certified applicators who have also taken the required additional training.)
[43 FR 5790, Feb. 9, 1978, as amended at 44 FR 45132, Aug. 1, 1979; 46 FR 5698, Jan. 19, 1981. Redesignated and amended at 53 FR 15988, May 4, 1988; 60 FR 32096, June 19, 1995]
Subparts J–T [Reserved]
§ 152.401 Inapplicability of fee provisions to applications filed prior to
October 1, 1997.
Subpart U—Registration Fees
No fee required by this subpart U
shall be levied with respect to any application filed during the period beginning on October 25, 1988, and ending on
September 30, 1997. See FIFRA section
4(i)(7) (added to FIFRA by Pub. L. 100–
532, October 25, 1988, 102 Stat. 2654).
SOURCE: 53 FR 19114, May 26, 1988, unless
otherwise noted.
§ 152.400
Purpose.
wreier-aviles on DSK7SPTVN1PROD with CFR
Subpart U prescribes fees to be
charged for the pesticide regulatory activities set forth in § 152.403 as performed by the Environmental Protection Agency (as authorized by 31 U.S.C.
9701 and Pub. L. 100–202) and provisions
regarding their payment.
[53 FR 11923, Mar. 22, 1989]
§ 152.403
Definitions of fee categories.
(a) New chemical registration review
means review of an application for registration of a pesticide product containing a chemical active ingredient
which is not contained as an active ingredient in any other pesticide product
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Environmental Protection Agency
§ 152.408
that is registered under FIFRA at the
time the application is made.
(b) New biochemical and microbial registration review means review of an application for registration of a biochemical or microbial pesticide product containing a biochemical or microbial active ingredient not contained in
any other pesticide product that is registered under FIFRA at the time the
application is made. For purposes of
this subpart, the definitions of biochemical and microbial pesticides contained in § 158.2000 and § 158.2100, respectively, shall apply.
(c) New use pattern registration review
means review of an application for registration, or for amendment of a registration entailing a major change to
the use pattern of an active ingredient
contained in a product registered under
FIFRA or pending Agency decision on
a prior application at the time of application. For purposes of this paragraph,
examples of major changes include but
are not limited to, changes from nonfood to food use, outdoor to indoor use,
ground to aerial application, terrestrial to aquatic use, and non-residential to residential use.
(d) Old chemical registration review
means review of an application for registration of a new product containing
active ingredients and uses which are
substantially similar or identical to
those currently registered or for which
an application is pending Agency decision.
(e) Amendment review means review of
any application requiring Agency approval to amend the registration of a
currently registered product, or for
which an application is pending Agency
decision, not entailing a major change
to the use pattern of an active ingredient.
(f) Experimental use permit review
means review of an application for a
permit pursuant to section 5 of FIFRA
to apply a limited quantity of a pesticide in order to accumulate information necessary to register the pesticide.
The application may be for a new
chemical or for a new use of an old
chemical. The fee applies to such experimental uses of a single unregistered active ingredient (no limit on the
number of other active ingredients, in
a tank mix, already registered for the
crops involved) and no more than three
crops. This fee does not apply to experimental use permits required for smallscale field testing of microbial pest
control agents (40 CFR 172.3).
[53 FR 19114, May 26, 1988, as amended at 72
FR 61028, Oct. 26, 2007]
§ 152.404
Fee amounts.
The fee prescribed by the following
table must be submitted with each application for registration, amended
registration or experimental use permit. Fees will be adjusted annually in
accordance with § 152.410. The Agency
may waive or refund fees in accordance
with § 152.412.
TABLE—REGISTRATION FEES
Type of review
Fee
New chemical ........................................................
New biochemical or microbial ...............................
New use pattern ....................................................
Experimental use permit ........................................
Old chemical ..........................................................
Amendment ...........................................................
$184,500
64,000
33,800
4,500
4,000
700
[53 FR 19114, May 26, 1988, as amended at 58
FR 34203, June 23, 1993]
§ 152.406 Submission of supplementary
data.
Applicants may submit data to supplement pending applications without
incurring additional charges if the
proper fee was paid with submission of
the original application and subsequent
submissions of supplementary data do
not constitute a change in the type of
registration action requested.
[53 FR 19114, May 26, 1988, as amended at 58
FR 34203, June 23, 1993]
§ 152.408
Special considerations.
(a) If two or more applicants apply
for a new chemical registration for
products having the same active ingredient and each applicant provides a set
of data in support of the registration
developed independently of the other
applicants’ data, then each applicant
submitting an independent set of data
shall be charged the full new chemical
registration review fee.
(b) If two or more applicants apply
for a new chemical registration for
products having the same active ingredient and the applicants have jointly
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§ 152.410
40 CFR Ch. I (7–1–11 Edition)
this fee will be waived. The announcement of the fee waiver will accompany
the EPA request for an amendment.
The Agency will not approve any individual requests for waivers of EPA-initiated activity fees.
(c) Waiver of fees for activities initiated
by applicants. Upon request by an applicant, together with the supporting documentation or justification described
in this paragraph, the Agency may
waive or refund fees in whole or in
part. A request for waiver must be submitted in accordance with § 152.414(a).
An application for which a waiver of
fees has been requested will not be accepted for review until the waiver has
been granted, or until the waiver has
been denied and thereafter the proper
fee has been submitted.
(1) Minor use. Fees may be waived for
applications limited to minor uses that
lack commercial feasibility for the pesticide applicant. An applicant requesting a waiver on this basis must provide
supporting information that demonstrates that anticipated revenues
from the uses that are the subject of
the application would be insufficient to
pay back the cost of the fee. The burden of proof of the reasonableness of
this estimate rests with the applicant.
(2) IR–4. Fees will be waived for registration actions that are determined
to be specifically associated with tolerance petitions submitted by the InterRegional Research Project Number 4
(IR–4 program) when such waiver is
deemed by the Agency to be in the public interest.
(3) Severe economic impact. The Agency may waive two-thirds of any cumulative registration fee payment in a 12month period following completion of
the applicant’s most recent fiscal year
that exceeds 3 percent of the applicant’s pesticide sales in its most recently completed fiscal year. An applicant requesting a waiver on this basis
must provide documentation (e.g. copy
of an annual report, or income tax
forms filed with the Internal Revenue
Service, or if needed, a notarized statement signed by a corporate officer regarding annual pesticide sales) demonstrating that:
(i) The company applying had less
than $40 million in gross revenue (including all revenue sources) in the
developed or paid for the joint development of a common set of data to support their applications for registration,
then each applicant shall be charged an
equal share of the total fee for review
of the applications for all of the subject
products. The total fee will include the
sum of the new chemical registration
review fee for one product and one old
chemical registration review fee for
each additional product.
(c) If an application is received for
registration of a product that contains
two or more new chemical active ingredients and a different set of generic
data is required by the Agency for each
new chemical for the purpose of registration, the applicant will be required
to pay the full new chemical registration review fee for each active ingredient.
wreier-aviles on DSK7SPTVN1PROD with CFR
§ 152.410 Adjustment of fees.
(a) The fee schedule will be adjusted
annually by the same percentage as the
percent change in the Federal General
Schedule (GS) pay scale. Such adjustments will be published in the FEDERAL
REGISTER as a final rule and will be effective 30 days or more after promulgation.
(b) Processing costs and fees will be
reviewed periodically and changes will
be made to the schedule as necessary.
Such adjustments will be published for
notice and comment in the FEDERAL
REGISTER.
§ 152.412 Waivers and refunds.
(a) Refunds. If an application is not
accepted for processing because it is incomplete, the fee, less $1,200 for handling and initial review (or the amount
of the fee, whichever is less), shall be
returned. If an application is withdrawn by the applicant before significant Agency scientific review has
begun, the fee, less $1,200, shall be returned. If an unacceptable or withdrawn petition is resubmitted, it shall
be accompanied by the fee that would
be required if it were submitted for the
first time.
(b) Waiver of fees for activities initiated
by the Agency. The Agency may waive
fees for amended registrations where
the amendment has been initiated solely by the Agency. The Agency retains
sole discretion in determining when
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Environmental Protection Agency
§ 152.500
actual fee is submitted to an address
different than the one to which the
waiver request is submitted, a copy of
the payment document must be submitted with the waiver request that is
submitted to the Office of Pesticide
Programs’ Document Processing Desk
as described in paragraph (a)(1) of this
section. No fee is required from a person who has no financial interest in the
application.
(b) Procedures for payment of fees. All
fees required by this section must be
paid by money order, bank draft, or
certified check drawn to the order of
the Environmental Protection Agency.
All payment of fees must be forwarded
to the Environmental Protection Agency, Headquarters Accounting Operations Branch, Office of Pesticide Programs (Registration Fees), P.O. Box
360277M, Pittsburgh, PA 15251. The payments should be specifically labeled
‘‘Registration Fees’’ and should be accompanied only by a copy of the registration application form or the experimental use permit application form,
as appropriate. An application will not
be accepted for processing until the required fees have been submitted.
(c) Procedures for submitting application and supporting data. The application, along with supporting data, shall
be forwarded within 30 days of payment
to the Washington DC address set forth
in paragraph (a)(1) of this section.
most recently concluded fiscal year of
operation, and a single fee would constitute more than 3 percent of the applicant’s gross revenue from pesticide
sales in the most recently completed
fiscal year of operation, or
(ii) The company applying had less
than $40 million in gross revenue (including all revenue sources) in the
most recently concluded fiscal year of
operation, and the cumulative registration fees paid during the 12 months following the applicant’s most recently
completed fiscal year, including any
registration fees paid for the applicant
for which a waiver is requested, constitute more than 3 percent of the applicant’s gross revenue from pesticide
sales in the most recently concluded
fiscal year of operation.
(iii) The Agency will not grant such a
waiver if it determines that the entity
submitting the application has been
formed or manipulated to qualify for
such a waiver.
(4) Public interest. The Agency, in its
discretion, may waive in whole or in
part any of the fees established herein
in the public interest. Examples include, but are not limited to, pesticides
offering unique advantages for reducing public health risks, those that significantly reduce a current environmental risk, or a product with extraordinary utility for use in Integrated
Pest Management (IPM).
wreier-aviles on DSK7SPTVN1PROD with CFR
[53 FR 19114, May 26, 1988, as amended at 58
FR 34203, June 23, 1993]
[53 FR 19114, May 26, 1988, as amended at 58
FR 34203, June 23, 1993; 69 FR 39864, July 1,
2004; 71 FR 35545, June 21, 2006]
§ 152.414 Procedures.
(a) Procedures for requesting a waiver.
(1) A request for a waiver must be submitted in writing at the time the application is submitted to the Office of
Pesticide Programs’ Document Processing Desk at the appropriate address
as set forth in 40 CFR 150.17(a) or (b).
(2) A payment of $1,200 for processing
the waiver or the amount of the actual
fee, whichever is less, must be submitted simultaneously to the address
set forth in paragraph (b) of this section. This fee will be refunded (or applied to any resulting partial fee) if the
waiver is granted. Payment of fees for
the registration activities, in contrast
to the waiver fee, shall not be required
until the Agency makes a determination on the waiver request. Since the
Subparts V–Y [Reserved]
Subpart Z—Devices
§ 152.500
Requirements for devices.
(a) A device is defined as any instrument or contrivance (other than a firearm) intended for trapping, destroying,
repelling, or mitigating any pest or
any other form of plant or animal life
(other than man and other than a bacterium, virus, or other microorganism
on or in living man or living animals)
but not including equipment used for
the application of pesticides (such as
tamper-resistant
bait
boxes
for
rodenticides) when sold separately
therefrom.
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Pt. 153
40 CFR Ch. I (7–1–11 Edition)
(b) A device is not required to be registered under FIFRA sec. 3. The Agency has issued a policy statement concerning its authority and activities
with respect to devices, which was published in the FEDERAL REGISTER of November 19, 1976 (41 FR 51065). A device
is subject to the requirements set forth
in:
(1) FIFRA sec. 2(q)(1) and part 156 of
this chapter, with respect to labeling;
(2) FIFRA sec. 7 and part 167 of this
chapter, with respect to establishment
registration and reporting;
(3) FIFRA sec. 8 and part 169 of this
chapter, with respect to books and
records;
(4) FIFRA sec. 9, with respect to inspection of establishments;
(5) FIFRA sec. 12, 13, and 14, with respect to violations, enforcement activities, and penalties;
(6) FIFRA sec. 17, with respect to import and export of devices;
(7) FIFRA sec. 25(c)(3), with respect
to child-resistant packaging; and
(8) FIFRA sec. 25(c)(4), with respect
to the Agency’s authority to declare
devices subject to certain provisions of
the Act.
Subpart G—Determination of
Active and Inert Ingredients
SOURCE: 53 FR 15989, May 4, 1988, unless
otherwise noted.
§ 153.125 Criteria for determination of
pesticidal activity.
(a) An ingredient will be considered
an active ingredient if it is contained
in a pesticide product and:
(1) The ingredient has the capability
by itself, and when used as directed at
the proposed use dilution, to function
as a pesticide; or
(2) The ingredient has the ability to
elicit or enhance a pesticidal effect in
another compound whose pesticidal activity is substantially increased due to
the interaction of the compounds.
Compounds which function simply to
enhance or prolong the activity of an
active ingredient by physical action,
such as stickers and other adjuvants,
are not generally considered to be active ingredients.
(b) Normally the applicant will determine and state in his application
whether an ingredient is active or inert
with respect to pesticidal activity. The
Agency, as part of its review of an application for registration, or in conjunction with the Registration Standard or Special Review process, may require any ingredient, to be designated
as an active ingredient if the Agency
finds that it meets the criteria in paragraph (a) of this section. Conversely,
the Agency may determine that any ingredient designated as active by an applicant is an inert ingredient if it fails
to meet those criteria.
(c) If an ingredient is designated as
an active ingredient, it must be identified in the label ingredients statement.
If an ingredient is designated as an
inert ingredient, it must be included as
part of the total inert ingredients in
the label ingredients statement.
(d) Designation of a substance as a
pesticidally inert ingredient does not
relieve the applicant or registrant of
other requirements of FIFRA with respect to labeling of inert ingredients or
submission of data, or from the requirements of the Federal Food, Drug,
[53 FR 15990, May 4, 1988. Redesignated at 60
FR 32096, June 19, 1995]
PART 153—REGISTRATION POLICIES
AND INTERPRETATIONS
Subparts A–F [Reserved]
Subpart G—Determination of Active and
Inert Ingredients
Sec.
153.125 Criteria for determination of pesticidal activity.
Subpart H—Coloration and Discoloration of
Pesticides
153.140
153.155
General.
Seed treatment products.
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Subparts I–M [Reserved]
AUTHORITY: 7 U.S.C. 136w.
Subparts A–F [Reserved]
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| File Type | application/pdf |
| File Modified | 2014-08-18 |
| File Created | 2014-08-18 |